Easy Apply
36
Date posted
Work from home options
Commute time
Application method
Job language
Skills
Categories
Sectors
Regions
Cities
Experience
Type of Contract
Type of Work
Filters
SortingRelevance
Work from home options
Commute time
Application method
Job language
Skills
Categories
Sectors
Regions
Cities
Experience
Type of Contract
Type of Work
146 results for Governance, Risk and Compliance Consultant jobs in Brussels within a 30 km radius
){kind=logo}
As a Governance, Risk and ion our ICT Risk team, you will be part of consulting engagements responsible for managing, controlling, and mitigating client's risk management strategies. Capco ICT RISK is a multi-faceted team focused on the evaluation, strategy definition, and execution of risk-minded solutions for leading organizations across the Financial Services industry. We provide customized results, adapting enterprise risk management strategies to potential cyber pitfalls. Capco has experience assisting financial institutions' leadership on top cyber security priorities through a team with expertise in financial business processes, strategic advisory, cyber programs and * Perform reviews of platforms and services to assess cyber risks around security risks such as data leakage and unauthorized access, and design controls to mitigate those risks
As a Governance, Risk and ion our ICT Risk team, you will be part of consulting engagements responsible for managing, controlling, and mitigating client's risk management strategies. Capco ICT RISK is a multi-faceted team focused on the evaluation, strategy definition, and execution of risk-minded solutions for leading organizations across the Financial Services industry. We provide customized results, adapting enterprise risk management strategies to potential cyber pitfalls. Capco has experience assisting financial institutions' leadership on top cyber security priorities through a team with expertise in financial business processes, strategic advisory, cyber programs and * Perform reviews of platforms and services to assess cyber risks around security risks such as data leakage and unauthorized access, and design controls to mitigate those risks
No match yet? There are 145 more jobs that could match your search
){kind=logo}
Over the last 30 years, the European Standardization System has delivered more than 3600 harmonized standards, allowing industry and SMEs to demonstrate compliance with EU law in a resource and cost-efficient way. Standards make our lives safer, simpler, more comfortable and more efficient. CEN and CENELEC, based in Brussels, are internationally recognized non-profit associations and officially designated European Standardization Organizations (alongside ETSI). Representing 43 members and employing 95 professionals, we play a pivotal role in driving a resilient, green, and digital EU Single Market. Two years ago, the Harmonised Standards Compliance (HSC) unit was created to enhance the quality of draft standards. In this role, you will report directly to the and work alongside two colleagues. * performing assessment on draft Harmonized Standards content against predefined criteria, to support ...
Over the last 30 years, the European Standardization System has delivered more than 3600 harmonized standards, allowing industry and SMEs to demonstrate compliance with EU law in a resource and cost-efficient way. Standards make our lives safer, simpler, more comfortable and more efficient. CEN and CENELEC, based in Brussels, are internationally recognized non-profit associations and officially designated European Standardization Organizations (alongside ETSI). Representing 43 members and employing 95 professionals, we play a pivotal role in driving a resilient, green, and digital EU Single Market. Two years ago, the Harmonised Standards Compliance (HSC) unit was created to enhance the quality of draft standards. In this role, you will report directly to the and work alongside two colleagues. * performing assessment on draft Harmonized Standards content against predefined criteria, to support ...
){kind=logo}
Binnen het Data Office speel je een sleutelrol bij het opzetten en aansturen van een modern, coherent en op datavalorisatie gericht data governance. • De rollen en verantwoordelijkheden voor Data bepalen en operationeel governance stimuleren. • Leiding geven aan het Data Governance- & Data Quality-team en rapporteren aan de Data Officer. • Normen, beleid en goede praktijken op het gebied van gegevensbeheer definiëren en verspreiden, bewustzijn creëren voor nieuwe regelgevingskaders zoals de European Data Governance Act, de AI Act en de European Health Data Space (EHDS). Je hebt minimaal 5 jaar ervaring in data management of data governance in een grote organisatie.
Binnen het Data Office speel je een sleutelrol bij het opzetten en aansturen van een modern, coherent en op datavalorisatie gericht data governance. • De rollen en verantwoordelijkheden voor Data bepalen en operationeel governance stimuleren. • Leiding geven aan het Data Governance- & Data Quality-team en rapporteren aan de Data Officer. • Normen, beleid en goede praktijken op het gebied van gegevensbeheer definiëren en verspreiden, bewustzijn creëren voor nieuwe regelgevingskaders zoals de European Data Governance Act, de AI Act en de European Health Data Space (EHDS). Je hebt minimaal 5 jaar ervaring in data management of data governance in een grote organisatie.
){kind=logo}
Vanaf uw indiensttreding neemt u ook de rol op van Functionaris voor Gegevensbescherming (DPO) en draagt u actief bij aan het versterken van de juridische en compliance‑governance van APRIL Belgium, zowel lokaal als op groepsniveau. * gevarieerde dossiers op het snijvlak van recht, compliance, verzekering en governance, Als Legal & Compliance Manager bent u het centrale aanspreekpunt voor alle juridische, reglementaire en compliancevraagstukken binnen de organisatie. * Aansturen van de reglementaire compliance (AVG/GDPR, IDD/DDA, AML/CFT) * Minstens 3 jaar ervaring in compliance en/of 3 jaar ervaring in de verzekeringssector * Permanente opleidingen (juridisch, compliance, DPO, verzekeringen)
Vanaf uw indiensttreding neemt u ook de rol op van Functionaris voor Gegevensbescherming (DPO) en draagt u actief bij aan het versterken van de juridische en compliance‑governance van APRIL Belgium, zowel lokaal als op groepsniveau. * gevarieerde dossiers op het snijvlak van recht, compliance, verzekering en governance, Als Legal & Compliance Manager bent u het centrale aanspreekpunt voor alle juridische, reglementaire en compliancevraagstukken binnen de organisatie. * Aansturen van de reglementaire compliance (AVG/GDPR, IDD/DDA, AML/CFT) * Minstens 3 jaar ervaring in compliance en/of 3 jaar ervaring in de verzekeringssector * Permanente opleidingen (juridisch, compliance, DPO, verzekeringen)
){kind=logo}
Als Compliance & Competence Manager Food Certification (M/V/X) neem je een sleutelrol op in het borgen van de kwaliteit, onafhankelijkheid en de competenties binnen het team. Compliance
Als Compliance & Competence Manager Food Certification (M/V/X) neem je een sleutelrol op in het borgen van de kwaliteit, onafhankelijkheid en de competenties binnen het team. Compliance
NEW
Expertise in Operational Risk Management, Internal Control, and Internal Governance. As Operational Risk & Control Expert you are the linking pin between the central and local risk management functions, providing effective, independent oversight and monitoring of non-financial risks. The Operational Risk Team coordinates the risk management control activities, assesses potential risks and reports all operational and business risks to enable the Executive Board to monitor their overall risk profile so that risk triggers and limits are identified at an early stage and suitable countermeasures could be taken. * Collaborate with all departments and teams involved in controlling and monitoring operational risks, and report to the central Operational Risks team. * Identify, measure, and report on operational risks within the entities' Risk framework.
Expertise in Operational Risk Management, Internal Control, and Internal Governance. As Operational Risk & Control Expert you are the linking pin between the central and local risk management functions, providing effective, independent oversight and monitoring of non-financial risks. The Operational Risk Team coordinates the risk management control activities, assesses potential risks and reports all operational and business risks to enable the Executive Board to monitor their overall risk profile so that risk triggers and limits are identified at an early stage and suitable countermeasures could be taken. * Collaborate with all departments and teams involved in controlling and monitoring operational risks, and report to the central Operational Risks team. * Identify, measure, and report on operational risks within the entities' Risk framework.
Advise and help clients understand cybersecurity compliance issues, identify risks, and offer solutions. The Cybersecurity Regulatory Affairs Team is focused on developing strategies to support cybersecurity regulatory compliance, providing cybersecurity compliance counseling, leading strategic compliance initiatives, reporting security incidents and responding to regulatory inquiries, and shaping the development of cybersecurity laws worldwide. Cybersecurity and cyber threats are some of the greatest and highest impact risks to organizations and the tech industry today. The attorney in this role will support cybersecurity and resilience compliance programs for laws and regulations around the world, with a focus on laws and regulations in Europe, including providing advice on requirements under European laws and engagement with regulatory authorities as needed.
Advise and help clients understand cybersecurity compliance issues, identify risks, and offer solutions. The Cybersecurity Regulatory Affairs Team is focused on developing strategies to support cybersecurity regulatory compliance, providing cybersecurity compliance counseling, leading strategic compliance initiatives, reporting security incidents and responding to regulatory inquiries, and shaping the development of cybersecurity laws worldwide. Cybersecurity and cyber threats are some of the greatest and highest impact risks to organizations and the tech industry today. The attorney in this role will support cybersecurity and resilience compliance programs for laws and regulations around the world, with a focus on laws and regulations in Europe, including providing advice on requirements under European laws and engagement with regulatory authorities as needed.
){kind=logo}
Dossierbeheerder Ondernemingen Vanbreda Huysmans - Mechelen
Dossierbeheerder Ondernemingen Vanbreda Huysmans - Mechelen
VANBREDA RISK & BENEFITS
Mechelen
Partially remote
VANBREDA RISK & BENEFITS
VANBREDA RISK & BENEFITS
NEW
Executes projects inside live production datacenters in strict adherence to safety, security, and change-management standards, including MOP/SOP compliance and access controls; follows and reports any safety or security issues or concerns immediately. * Proactively identifies schedule, technical, safety, and operational risks, suggests ways to reduce maintenance risk, and develops mitigation and contingency plans in collaboration with relevant teams. Our infrastructure is comprised of a large global portfolio of more than 400 data centers in 70 regions and millions of servers. Our foundation is built upon and managed by a team of working to support services for more than 1 billion customers and 20 million businesses in over 90 countries worldwide. With environmental sustainability and optimization at the forefront of our data center design and ...
Executes projects inside live production datacenters in strict adherence to safety, security, and change-management standards, including MOP/SOP compliance and access controls; follows and reports any safety or security issues or concerns immediately. * Proactively identifies schedule, technical, safety, and operational risks, suggests ways to reduce maintenance risk, and develops mitigation and contingency plans in collaboration with relevant teams. Our infrastructure is comprised of a large global portfolio of more than 400 data centers in 70 regions and millions of servers. Our foundation is built upon and managed by a team of working to support services for more than 1 billion customers and 20 million businesses in over 90 countries worldwide. With environmental sustainability and optimization at the forefront of our data center design and ...
VANBREDA RISK & BENEFITS - Sinds 2012 maakt het kantoor deel uit van onze Vanbreda Risk & Benefits groep.
VANBREDA RISK & BENEFITS - Sinds 2012 maakt het kantoor deel uit van onze Vanbreda Risk & Benefits groep.
NEW
){kind=logo}
Easy Apply
Handling VAT declarations and ensuring compliance with local regulations - Our client is a well-established and growing company in the service sector, located in the Brussels region. The organization combines stability with a forward-looking mindset, offering a dynamic and international work environment. You will join a human-sized team where collaboration, autonomy, and trust are key values. The company promotes a supportive atmosphere, with accessible management and a real focus on work-life balance. As a Senior Accountant, you will play a key role in the finance team and work with a high level of autonomy. * Preparing monthly, quarterly, and annual closings * Supervising and improving accounting processes * Preparing financial reports and supporting budgeting and forecasting activities * Acting as a point of contact for auditors and external partners
Handling VAT declarations and ensuring compliance with local regulations - Our client is a well-established and growing company in the service sector, located in the Brussels region. The organization combines stability with a forward-looking mindset, offering a dynamic and international work environment. You will join a human-sized team where collaboration, autonomy, and trust are key values. The company promotes a supportive atmosphere, with accessible management and a real focus on work-life balance. As a Senior Accountant, you will play a key role in the finance team and work with a high level of autonomy. * Preparing monthly, quarterly, and annual closings * Supervising and improving accounting processes * Preparing financial reports and supporting budgeting and forecasting activities * Acting as a point of contact for auditors and external partners
){kind=logo}
Easy Apply
Managing project plans, governance, and timelines related to a warehouse transfer * Setting up 3PL operations and implementing changes in the distribution network * Ensuring efficient IT flows and optimizing processes * Fluency in French and English
Managing project plans, governance, and timelines related to a warehouse transfer * Setting up 3PL operations and implementing changes in the distribution network * Ensuring efficient IT flows and optimizing processes * Fluency in French and English
){kind=logo}
Als Power BI Developer and Administrator werk je als medewerker van Paradigm samen met onze Parking.brussels, de toonaangevende en van parkeerbeheeroplossingen in het Brussels Hoofdstedelijk Gewest. Als Power BI Developer and Administrator speel je een centrale rol in het vertalen van vakgebonden behoeften naar relevante reportingoplossingen, door datamodellen en rapporten te ontwerpen die zijn afgestemd op de stuurdoelstellingen van de organisatie. - Een Power BI-governance-strategie definiëren en implementeren die is aangepast aan Parking.brussels (werkruimten, levenscyclus, nomenclatuur, validatie, documentatie, releasebeheer...). - De ingevoerde procedures, governance-regels en configuraties documenteren. * Kennis van de principes van BI-governance en documentatiepraktijken.
Als Power BI Developer and Administrator werk je als medewerker van Paradigm samen met onze Parking.brussels, de toonaangevende en van parkeerbeheeroplossingen in het Brussels Hoofdstedelijk Gewest. Als Power BI Developer and Administrator speel je een centrale rol in het vertalen van vakgebonden behoeften naar relevante reportingoplossingen, door datamodellen en rapporten te ontwerpen die zijn afgestemd op de stuurdoelstellingen van de organisatie. - Een Power BI-governance-strategie definiëren en implementeren die is aangepast aan Parking.brussels (werkruimten, levenscyclus, nomenclatuur, validatie, documentatie, releasebeheer...). - De ingevoerde procedures, governance-regels en configuraties documenteren. * Kennis van de principes van BI-governance en documentatiepraktijken.
from a local and pragmatic setup towards increased structure, standardization and enterprise IT governance, with greater focus on security and compliance at European level. * Active involvement in IT security and compliance Are you looking for a role where you have real ownership, help shape structure, security and standards, and make a visible impact in an international context? * You will join an international industrial organization, firmly rooted in Belgium and operating across several European locations. Active in infrastructure and industrial activities, the company is known for its no‑nonsense culture, strong technical expertise and long-term vision. * This creates an excellent opportunity for an IT professional who enjoys bringing structure, progress and sustainability. As an IT System Engineer, you are responsible for the reliability, security and continuous evolution ...
from a local and pragmatic setup towards increased structure, standardization and enterprise IT governance, with greater focus on security and compliance at European level. * Active involvement in IT security and compliance Are you looking for a role where you have real ownership, help shape structure, security and standards, and make a visible impact in an international context? * You will join an international industrial organization, firmly rooted in Belgium and operating across several European locations. Active in infrastructure and industrial activities, the company is known for its no‑nonsense culture, strong technical expertise and long-term vision. * This creates an excellent opportunity for an IT professional who enjoys bringing structure, progress and sustainability. As an IT System Engineer, you are responsible for the reliability, security and continuous evolution ...
NEW
){kind=logo}
Easy Apply
You will play a key role in ensuring compliance, managing tax risks, and supporting strategic decisions. * Guarantee compliance with European and local tax regulations. Identify and manage tax risks, including indirect taxes and customs duties. Are you an experienced tax professional looking to take ownership of tax compliance at a European level? Our client, an international and fast-growing organization, is looking for a Tax Analyst to strengthen its Finance team. * Ensure timely and accurate submission of VAT returns, Intrastat declarations, EC * Sales Lists, and Corporate Income Tax returns (in collaboration with external ). * Monitor regulatory changes and assess their impact on the business. * Coordinate tax audits and prepare the required documentation. * Oversee all VAT matters, ensuring correct treatment of domestic, intra-EU, and international transactions.
You will play a key role in ensuring compliance, managing tax risks, and supporting strategic decisions. * Guarantee compliance with European and local tax regulations. Identify and manage tax risks, including indirect taxes and customs duties. Are you an experienced tax professional looking to take ownership of tax compliance at a European level? Our client, an international and fast-growing organization, is looking for a Tax Analyst to strengthen its Finance team. * Ensure timely and accurate submission of VAT returns, Intrastat declarations, EC * Sales Lists, and Corporate Income Tax returns (in collaboration with external ). * Monitor regulatory changes and assess their impact on the business. * Coordinate tax audits and prepare the required documentation. * Oversee all VAT matters, ensuring correct treatment of domestic, intra-EU, and international transactions.
Je hebt minstens 3 jaar ervaring in Azure-omgevingen en een sterke expertise in Azure Networking, Cost Management, Governance en Security, Automation via Bicep of PowerShell.
Je hebt minstens 3 jaar ervaring in Azure-omgevingen en een sterke expertise in Azure Networking, Cost Management, Governance en Security, Automation via Bicep of PowerShell.
){kind=logo}
Develop and execute guidance on industrial AI, autonomous machines, AI Act compliance, and AI governance; A connected machine, an AI-driven process, or a digital product carries risks that are just as real as a faulty industrial process, and the consequences of getting it wrong can be just as severe. * Deliver OT security consulting, gap assessments, and risk quantification for asset owners, system integrators, and product manufacturers; * Support companies in achieving certification for CRA, IEC 62443 (2-4, 3-3, 4-1, 4-2), ISO 27001, CyFun and NIS2 compliance; * Conduct independent cybersecurity and AI security assessments, penetration tests, and third-party risk assessments; * Help guiding companies in building governance frameworks combining ISO 27001, CyFun, and IEC 62443; Is this machine, product, process, or company safe, trustworthy and compliant?
Develop and execute guidance on industrial AI, autonomous machines, AI Act compliance, and AI governance; A connected machine, an AI-driven process, or a digital product carries risks that are just as real as a faulty industrial process, and the consequences of getting it wrong can be just as severe. * Deliver OT security consulting, gap assessments, and risk quantification for asset owners, system integrators, and product manufacturers; * Support companies in achieving certification for CRA, IEC 62443 (2-4, 3-3, 4-1, 4-2), ISO 27001, CyFun and NIS2 compliance; * Conduct independent cybersecurity and AI security assessments, penetration tests, and third-party risk assessments; * Help guiding companies in building governance frameworks combining ISO 27001, CyFun, and IEC 62443; Is this machine, product, process, or company safe, trustworthy and compliant?
Als Data Functional Analyst maak je deel uit van het Data Office, waar multidisciplinaire agile-teams werken (Data Engineer, Project Leader, Data Architects, Data Governance- en Data Quality-specialisten, AI-Experts, enz.).
Als Data Functional Analyst maak je deel uit van het Data Office, waar multidisciplinaire agile-teams werken (Data Engineer, Project Leader, Data Architects, Data Governance- en Data Quality-specialisten, AI-Experts, enz.).
){kind=logo}
Samen met Legal en Finance zorg je voor correcte verslaggeving, governance en compliance. Je focust op governance, strategische keuzes en een kwalitatieve vertaling naar beleid en uitvoering. * Beleidsadvies & governance: je ontwikkelt en implementeert een heldere Reward & Mobility‑strategie, vertaalt de Group‑ en P&O‑prioriteiten naar concreet beleid en waakt over een consequente toepassing binnen functiehuis, verloning en mobiliteit. Je hebt aantoonbare ervaring met , governance en besluitvorming in samenwerking met directie en boardorganen.
Samen met Legal en Finance zorg je voor correcte verslaggeving, governance en compliance. Je focust op governance, strategische keuzes en een kwalitatieve vertaling naar beleid en uitvoering. * Beleidsadvies & governance: je ontwikkelt en implementeert een heldere Reward & Mobility‑strategie, vertaalt de Group‑ en P&O‑prioriteiten naar concreet beleid en waakt over een consequente toepassing binnen functiehuis, verloning en mobiliteit. Je hebt aantoonbare ervaring met , governance en besluitvorming in samenwerking met directie en boardorganen.
• Indien nodig identificeer en beheer je de "risks & issues" en vervul je de rol van "crisismanager".
• Indien nodig identificeer en beheer je de "risks & issues" en vervul je de rol van "crisismanager".
){kind=logo}
Help identify risks, support mitigation actions, and escalate issues appropriately. * Maintain and update the inventory of Alliance Partnerships requiring QA involvement. * Support the creation and revision of Quality Agreements and prepare draft partner notifications for QA review. * Assist in initiating deviations and complaints in the system and support routine operational QA activities. * Follow up and maintain data accuracy in the CRM; perform regular CRM cleaning. * Launch IT tickets when needed and track them to closure. * Act as document controller: manage document lifecycle, ensure correct filing, and place documents into obsolescence. * Support preparation of Quality Management Review (QMR) data and team KPI tracking. * Coordinate basic communication and information exchange with partners under QA guidance. * Assist in preparing documentation for audits and inspections initiated by ...
Help identify risks, support mitigation actions, and escalate issues appropriately. * Maintain and update the inventory of Alliance Partnerships requiring QA involvement. * Support the creation and revision of Quality Agreements and prepare draft partner notifications for QA review. * Assist in initiating deviations and complaints in the system and support routine operational QA activities. * Follow up and maintain data accuracy in the CRM; perform regular CRM cleaning. * Launch IT tickets when needed and track them to closure. * Act as document controller: manage document lifecycle, ensure correct filing, and place documents into obsolescence. * Support preparation of Quality Management Review (QMR) data and team KPI tracking. * Coordinate basic communication and information exchange with partners under QA guidance. * Assist in preparing documentation for audits and inspections initiated by ...
Easy Apply
Coordinating team activities for the entire payroll process and ensuring accuracy, compliance, and deadline management. Join a dynamic organization offering an international and collaborative work environment. You will oversee a team of one Payroll Officer, ensuring the smooth operation of all administrative and payroll processes for 300 . * Ensuring Payroll/HR systems comply with relevant social law regulations and providing proactive advice on official procedures to tax authorities, NSSO, and others. * Working closely with HR, sales, mobility, and accounting teams to improve processes and workflows. * Providing operational support to the team and responding accurately to employee queries. * Managing and mentoring the , fostering a supportive and growth-oriented environment. * Overseeing the renewal and creation of work permits according to legal requirements. * Fluent in English, Dutch, and French.
Coordinating team activities for the entire payroll process and ensuring accuracy, compliance, and deadline management. Join a dynamic organization offering an international and collaborative work environment. You will oversee a team of one Payroll Officer, ensuring the smooth operation of all administrative and payroll processes for 300 . * Ensuring Payroll/HR systems comply with relevant social law regulations and providing proactive advice on official procedures to tax authorities, NSSO, and others. * Working closely with HR, sales, mobility, and accounting teams to improve processes and workflows. * Providing operational support to the team and responding accurately to employee queries. * Managing and mentoring the , fostering a supportive and growth-oriented environment. * Overseeing the renewal and creation of work permits according to legal requirements. * Fluent in English, Dutch, and French.
){kind=logo}
Deze afdeling staat in voor microbiële monitoring en validatie van aseptische processen op onze site en speelt een cruciale rol in het garanderen van kwaliteit en compliance.
Deze afdeling staat in voor microbiële monitoring en validatie van aseptische processen op onze site en speelt een cruciale rol in het garanderen van kwaliteit en compliance.
Als Data Engineer Health Sector maak je deel uit van het Data Office, waar multidisciplinaire Agile-teams werken (Data Engineer, Projectleiders, Data Architects, specialisten in Data Governance en Data Quality, AI-experts, enz.).
Als Data Engineer Health Sector maak je deel uit van het Data Office, waar multidisciplinaire Agile-teams werken (Data Engineer, Projectleiders, Data Architects, specialisten in Data Governance en Data Quality, AI-experts, enz.).
){kind=logo}
Develop fit-for-purpose standards and guidelines applicable to the QC analytical laboratory to achieve both scientific excellence and regulatory compliance in a commercial QC environment where New Product Introduction is in strategic focus. * Participate in global compendial vigilance & compliance process by review compendial updates for “General Chapters” of EP, USP, JP, ChP, IP, and BP and by facilitating their fit-for-purpose local implementation. * In-depth understanding of QbD, Quality Risk Management and lifecycle management principles, and relevant regulatory framework, such as ICH Q8, Q9, Q10, Q11, Q12. * Understanding of the principles of risk-based small-molecule process control strategy development, specification management (ICH Q6) and impurity management (ICH Q3 group of guidelines, ICH M7, latest regulatory standpoint on nitrosamines).
Develop fit-for-purpose standards and guidelines applicable to the QC analytical laboratory to achieve both scientific excellence and regulatory compliance in a commercial QC environment where New Product Introduction is in strategic focus. * Participate in global compendial vigilance & compliance process by review compendial updates for “General Chapters” of EP, USP, JP, ChP, IP, and BP and by facilitating their fit-for-purpose local implementation. * In-depth understanding of QbD, Quality Risk Management and lifecycle management principles, and relevant regulatory framework, such as ICH Q8, Q9, Q10, Q11, Q12. * Understanding of the principles of risk-based small-molecule process control strategy development, specification management (ICH Q6) and impurity management (ICH Q3 group of guidelines, ICH M7, latest regulatory standpoint on nitrosamines).