Risk Analysis Jobs in Flemish Brabant

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QA manager

Brunel Belgium NV

Boortmeerbeek

At the moment for example, we are looking for a quality assurance manager to consult one of out clients. * Minimum 5 years of experience in a QA-position, preferably in the Pharmaceutical-related Industry - Brunel Belgium NV * Boortmeerbeek * Contract duration unspecified * Full Time - About You - As a consultancy company specialized in Life Sciences, Infrastructure and IT we are looking for new consultants to . Your responsibilities * Advising on the translation of GDP-, GMP- and customer requirements that need to be integrated in the operational processes. Ensure the incorporation of such requirements in the procedures and instructions and provide training when necessary. * Follow-up of Quality-KPI's. * Review and alignment of Quality Technical Agreements with customers as well as with suppliers. At the moment for example, we are looking for a quality assurance manager to consult one of out clients. * Minimum 5 years of experience in a QA-position, preferably in the Pharmaceutical-related Industry - Brunel Belgium NV * Boortmeerbeek * Contract duration unspecified * Full Time - About You - As a consultancy company specialized in Life Sciences, Infrastructure and IT we are looking for new consultants to . Your responsibilities * Advising on the translation of GDP-, GMP- and customer requirements that need to be integrated in the operational processes. Ensure the incorporation of such requirements in the procedures and instructions and provide training when necessary. * Follow-up of Quality-KPI's. * Review and alignment of Quality Technical Agreements with customers as well as with suppliers.
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QA specialist

Brunel Belgium NV

Diegem

At the moment for example, we are looking for a quality assurance specialist to consult one of out clients. * Minimum 5 years of experience in a QA-position, preferably in the Pharmaceutical-related Industry - Brunel Belgium NV * Diegem * Contract duration unspecified * Full Time - About You - Are you someone who likes trying new things and gaining different experiences? Than life as a consultant might be your thing! As a consultancy company specialized in Life Sciences, Infrastructure and IT we are looking for new consultants to . Your responsibilities * Advising on the translation of GDP-, GMP- and customer requirements that need to be integrated in the operational processes. Ensure the incorporation of such requirements in the procedures and instructions and provide training when necessary. * Reporting and follow-up of Quality-KPI's. At the moment for example, we are looking for a quality assurance specialist to consult one of out clients. * Minimum 5 years of experience in a QA-position, preferably in the Pharmaceutical-related Industry - Brunel Belgium NV * Diegem * Contract duration unspecified * Full Time - About You - Are you someone who likes trying new things and gaining different experiences? Than life as a consultant might be your thing! As a consultancy company specialized in Life Sciences, Infrastructure and IT we are looking for new consultants to . Your responsibilities * Advising on the translation of GDP-, GMP- and customer requirements that need to be integrated in the operational processes. Ensure the incorporation of such requirements in the procedures and instructions and provide training when necessary. * Reporting and follow-up of Quality-KPI's.
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QA release officer

Oxford Global Resources

Geel

For one of our clients, located in Geel, we are currently looking for a "QA Release Officer". Our client is currently is looking for a candidate with at least a first experience as QA release officer. Oxford Global Resources * Geel * Contract duration specified * Full Time - Your responsibilities - Job Description - Responsibilities * Create deviation list * Review tests * Follow up and reporting of process control * Data verification * Check whether all batch records are closed * Regulatory checks: check in the system whether the relevant countries have approved a specific change, based on this make a list of the countries to which the batch can go. Do the above responsibilities fit you like a glove? and motivation letter via the " " button and you can expect feedback from us soon. Your profile - Requirements * Knowledge of Dutch and English * Knowledge of biotechnological process For one of our clients, located in Geel, we are currently looking for a "QA Release Officer". Our client is currently is looking for a candidate with at least a first experience as QA release officer. Oxford Global Resources * Geel * Contract duration specified * Full Time - Your responsibilities - Job Description - Responsibilities * Create deviation list * Review tests * Follow up and reporting of process control * Data verification * Check whether all batch records are closed * Regulatory checks: check in the system whether the relevant countries have approved a specific change, based on this make a list of the countries to which the batch can go. Do the above responsibilities fit you like a glove? and motivation letter via the " " button and you can expect feedback from us soon. Your profile - Requirements * Knowledge of Dutch and English * Knowledge of biotechnological process
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Document Controller

Parkwind NV

Leuven

For the development and construction of our current and future offshore wind farms, we are looking for Document Controller to reinforce our Projects Department. * Support our procedures maintaining transparent, up-to-date and easily traceable documents * Manage document flow throughout the organization * File documents in digital records * Creating and filing of incoming and outcoming documents during all project phases, using SharePoint document management system * Quality assurance of outgoing documents, e.g. tender documents, contracts, … Parkwind NV * Leuven * Contract duration unspecified * Full Time - Job description - As a 360° player in the offshore wind industry, Parkwind is one of Europe's leading companies in the field of developing, financing, constructing and operating offshore wind farms. For the development and construction of our current and future offshore wind farms, we are looking for Document Controller to reinforce our Projects Department. * Support our procedures maintaining transparent, up-to-date and easily traceable documents * Manage document flow throughout the organization * File documents in digital records * Creating and filing of incoming and outcoming documents during all project phases, using SharePoint document management system * Quality assurance of outgoing documents, e.g. tender documents, contracts, … Parkwind NV * Leuven * Contract duration unspecified * Full Time - Job description - As a 360° player in the offshore wind industry, Parkwind is one of Europe's leading companies in the field of developing, financing, constructing and operating offshore wind farms.
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QA assistant

SGS Group Belgium

Mechelen

In the spirit of continued growth and to help improve our business, we are currently seeking for a QA assistant. As QA assistant in the preparation, audits in accordance with internal procedures. SGS Group Belgium * Mechelen * Contract duration unspecified * Full Time - Company Description - At SGS, you can choose. First of all, out of our various vacancies. However, SGS also gives you another choice. Do you choose to expand or to enrich? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call 'connectors', people who can connect our diversity to our services. To each other. And this way, enrich our business. SGS is the world's leading inspection, verification, testing and certification company. We're also the benchmark worldwide for quality and integrity. And that makes us very proud. In the spirit of continued growth and to help improve our business, we are currently seeking for a QA assistant. As QA assistant in the preparation, audits in accordance with internal procedures. SGS Group Belgium * Mechelen * Contract duration unspecified * Full Time - Company Description - At SGS, you can choose. First of all, out of our various vacancies. However, SGS also gives you another choice. Do you choose to expand or to enrich? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call 'connectors', people who can connect our diversity to our services. To each other. And this way, enrich our business. SGS is the world's leading inspection, verification, testing and certification company. We're also the benchmark worldwide for quality and integrity. And that makes us very proud.
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QA Manager - GMP

Experis

Walloon Brabant

As QA Manager, you are in charge to - Experis * Walloon Brabant * Contract duration unspecified * Full Time - Your responsibilities - What are your responsibilities? * Ensure the availability, the update and continuous improvement of the quality management system, * Communicate operational issues and opportunities for improvement to department leaders, * Function as Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives in relation to Supplier qualification, self-inspection, Agency inspections and customer audits, * Contribute to the quality department's activities to ensure continuity of operations, * Know, understand and comply with the company's standard operation procedures and policies, * Perform other related job duties in the context of Quality Assurance as assigned by EU Director, * Perform and and vendors, As QA Manager, you are in charge to - Experis * Walloon Brabant * Contract duration unspecified * Full Time - Your responsibilities - What are your responsibilities? * Ensure the availability, the update and continuous improvement of the quality management system, * Communicate operational issues and opportunities for improvement to department leaders, * Function as Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives in relation to Supplier qualification, self-inspection, Agency inspections and customer audits, * Contribute to the quality department's activities to ensure continuity of operations, * Know, understand and comply with the company's standard operation procedures and policies, * Perform other related job duties in the context of Quality Assurance as assigned by EU Director, * Perform and and vendors,
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Benelux RA QA and Vigilance Manager

Arsanne Consulting SPRL

Brussels

ARSANNE Consulting is looking for a Benelux RA, QA and Vigilance Manager for the BENELUX affiliate of an entrepreneurial international pharmaceutical group. Knowledge of BENELUX pharmaceutical regulatory environment is an important asset. * Local Regulatory Contact Person for Marketing Authorizations. Arsanne Consulting SPRL * Brussels * Contract duration unspecified * Full Time - Introduction - Your Mission * You report directly to the General Management and you are responsible for Benelux. * You'll be in charge of the introduction and management of new and existing brands manufactured by the group within the BENELUX market. * Responsible Pharmacist assume the function in relation to GDP (article 12ter of the medicines law of 25 March 1964) as described into Royal Decree of 14 December 2006. * Acts as the local person for medical device distributor in accordance with the legislation of March 18th, 1999. ARSANNE Consulting is looking for a Benelux RA, QA and Vigilance Manager for the BENELUX affiliate of an entrepreneurial international pharmaceutical group. Knowledge of BENELUX pharmaceutical regulatory environment is an important asset. * Local Regulatory Contact Person for Marketing Authorizations. Arsanne Consulting SPRL * Brussels * Contract duration unspecified * Full Time - Introduction - Your Mission * You report directly to the General Management and you are responsible for Benelux. * You'll be in charge of the introduction and management of new and existing brands manufactured by the group within the BENELUX market. * Responsible Pharmacist assume the function in relation to GDP (article 12ter of the medicines law of 25 March 1964) as described into Royal Decree of 14 December 2006. * Acts as the local person for medical device distributor in accordance with the legislation of March 18th, 1999.
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Compliance Engineer

Brunel Belgium NV

Antwerpen

Are you the Compliance Engineer we are looking for? * Update data in compliance follow-up tools ( eg Trackwise, … * Closely work with client's engineers and plant representatives * Awareness of client's compliance procedures by following client's trainings * Approximately 1 to 5 years of experience in pharmaceutical industry in qualification/compliance activities - Brunel Belgium NV * Antwerpen * Contract duration unspecified * Full Time - About You - Does this vacancy match your profile? Don't hesitate and ! Your responsibilities * Changes initiated by production or maintenance * Changes initiated by project engineering groups (MAM , E&PS ) * Periodic reviews on the system's documentation to ensure these systems remain qualified (3year period) * Evaluate calibration deviations and initiate, follow up on and document corrective actions to bring instruments back in compliant condition. * Preparation of intakes. (Sr only) Your profile Are you the Compliance Engineer we are looking for? * Update data in compliance follow-up tools ( eg Trackwise, … * Closely work with client's engineers and plant representatives * Awareness of client's compliance procedures by following client's trainings * Approximately 1 to 5 years of experience in pharmaceutical industry in qualification/compliance activities - Brunel Belgium NV * Antwerpen * Contract duration unspecified * Full Time - About You - Does this vacancy match your profile? Don't hesitate and ! Your responsibilities * Changes initiated by production or maintenance * Changes initiated by project engineering groups (MAM , E&PS ) * Periodic reviews on the system's documentation to ensure these systems remain qualified (3year period) * Evaluate calibration deviations and initiate, follow up on and document corrective actions to bring instruments back in compliant condition. * Preparation of intakes. (Sr only) Your profile
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Clinical Data Manager

Brunel Belgium NV

Mechelen

Communication with all involved parties (EDC, STAT, MA, Clinical teams, Client, External Data Providers, Medical Writing, Project Manager Biometrics) … * Preferably, a minimum of 2 years of experience within Clinical Trial Data Management is required. As an experienced CDM you are the Data Management (DM) Lead who is, overall responsible for all the DM activities from the projects on which you are assigned. You are the owner of the clinical SDTM database for your clinical studies and will serve as the Point of Contact towards all involved parties and towards the client. You ensure that trustful, transparent, clean and consistent SDTM data is delivered to the Statistical team at database lock. * Review and testing of the Data Collection Tool (EDC Tool or eSource Tool) * Development of Data Management Plan * Create/review the Data Transfer Agreements with all External Data Providers Communication with all involved parties (EDC, STAT, MA, Clinical teams, Client, External Data Providers, Medical Writing, Project Manager Biometrics) … * Preferably, a minimum of 2 years of experience within Clinical Trial Data Management is required. As an experienced CDM you are the Data Management (DM) Lead who is, overall responsible for all the DM activities from the projects on which you are assigned. You are the owner of the clinical SDTM database for your clinical studies and will serve as the Point of Contact towards all involved parties and towards the client. You ensure that trustful, transparent, clean and consistent SDTM data is delivered to the Statistical team at database lock. * Review and testing of the Data Collection Tool (EDC Tool or eSource Tool) * Development of Data Management Plan * Create/review the Data Transfer Agreements with all External Data Providers
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RA Manager

Brunel Belgium NV

Vilvoorde

We are currently looking for a Regulatory Affairs Manager to join the team at our client's. * Ensure that processes, procedures and regulatory files are well documented in up to date and complete applicable archives, databases, repositories and trackers. * Secure timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention via the RA lead to the Management Team, such as deletions, divestitures and acquisitions. * Take part in affiliate product and launch teams to provide regulatory input and strategy advice. Brunel Belgium NV * Vilvoorde * Contract duration unspecified * Full Time - About You - Your responsibilities * Support implementation locally of new initiatives, management tools or processes in cooperation with EST- RA. * Contribute to the EST-RA and affiliate Quality Management System. We are currently looking for a Regulatory Affairs Manager to join the team at our client's. * Ensure that processes, procedures and regulatory files are well documented in up to date and complete applicable archives, databases, repositories and trackers. * Secure timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention via the RA lead to the Management Team, such as deletions, divestitures and acquisitions. * Take part in affiliate product and launch teams to provide regulatory input and strategy advice. Brunel Belgium NV * Vilvoorde * Contract duration unspecified * Full Time - About You - Your responsibilities * Support implementation locally of new initiatives, management tools or processes in cooperation with EST- RA. * Contribute to the EST-RA and affiliate Quality Management System.
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Clinical Project Manager (Phase II-III)

SGS Group Belgium

Mechelen

As Clinical Project Manager (CPM) at SGS you will provide leadership to a (cross-functional) team in the execution of clinical research projects (late phases). In the spirit of continued growth and to help improve our business, we are currently seeking for a Clinical Project Manager (Phase II-III). * You have at least 2 years of experience in an International Project Management role, having managed international phase 2 and 3 clinical trials in a pharmaceutical or biotech company or another CRO. SGS Life Sciences carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities. As Clinical Project Manager (CPM) at SGS you will provide leadership to a (cross-functional) team in the execution of clinical research projects (late phases). In the spirit of continued growth and to help improve our business, we are currently seeking for a Clinical Project Manager (Phase II-III). * You have at least 2 years of experience in an International Project Management role, having managed international phase 2 and 3 clinical trials in a pharmaceutical or biotech company or another CRO. SGS Life Sciences carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities.
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Quality Assurance Expert

EMVO ASBL

Brussels

As a Quality Assurance Expert, you will take responsibility to ensure compliance of EMVO's owned systems and services. As QA Expert, you will be part of a dynamic and international organisation, growing rapidly to meet the demands of the healthcare and pharmaceutical sector. You will be involved in successfully running an organisation which is critical to the European pharmaceutical supply chain and will be performing Quality Assurance activities in support of EMVO's Quality Management System. * Providing EMVO departments with support related to Quality Assurance * Representing EMVO Quality Assurance department in EMVS InterOperability Tests * Interacting closely with EMVO staff and providing them with Quality Assurance training. * Maintaining and supporting the Quality Management System * Following up on the Quality Events and CAPAs * Brussels * Contract duration unspecified * Full Time As a Quality Assurance Expert, you will take responsibility to ensure compliance of EMVO's owned systems and services. As QA Expert, you will be part of a dynamic and international organisation, growing rapidly to meet the demands of the healthcare and pharmaceutical sector. You will be involved in successfully running an organisation which is critical to the European pharmaceutical supply chain and will be performing Quality Assurance activities in support of EMVO's Quality Management System. * Providing EMVO departments with support related to Quality Assurance * Representing EMVO Quality Assurance department in EMVS InterOperability Tests * Interacting closely with EMVO staff and providing them with Quality Assurance training. * Maintaining and supporting the Quality Management System * Following up on the Quality Events and CAPAs * Brussels * Contract duration unspecified * Full Time
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