Jobs en tant que R&D, Science & Scientific Research à Antwerp Province

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GLP QA Manager

Real Staffing Brussels (International)

Beerse

The company is based in Beerse and is currently looking for a freelance / consultant GLP QA Manager. The GLP QA Manager will conduct supplier qualifications and risk assessments at third parties to check the qualifications for executing toxicological or bioanalytical testing. The GLP QA Manager will also be advising on quality incidents, deviations, CAPA's, ... related to the third party. Real Staffing Brussels (International) * Beerse * Freelance * Full Time - Real Staffing - Your responsibilities - For an international player in the pharmaceutical industry, I am looking for an experienced GLP professional. What am I looking for? * GLP (FDA part 58) * In a quality department * As a study director or study investigator * Conducting risk assessments and/or supplier qualifications * Fluent in English - This position can be 100% remote and executed from everywhere in Europe - Start date : ASAP - End date : end of the year The company is based in Beerse and is currently looking for a freelance / consultant GLP QA Manager. The GLP QA Manager will conduct supplier qualifications and risk assessments at third parties to check the qualifications for executing toxicological or bioanalytical testing. The GLP QA Manager will also be advising on quality incidents, deviations, CAPA's, ... related to the third party. Real Staffing Brussels (International) * Beerse * Freelance * Full Time - Real Staffing - Your responsibilities - For an international player in the pharmaceutical industry, I am looking for an experienced GLP professional. What am I looking for? * GLP (FDA part 58) * In a quality department * As a study director or study investigator * Conducting risk assessments and/or supplier qualifications * Fluent in English - This position can be 100% remote and executed from everywhere in Europe - Start date : ASAP - End date : end of the year
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System Verification Engineer

Nipro Europe Group Companies

Mechelen

As System Verification Engineer you take a leading role in planning, preparing, executing and documenting verification, validation and usability tests during the development of new dialysis equipment. To accommodate our growth, we are looking for a dynamic, hands-on System Verification Engineer at Nipro Europe Group Companies (NEGC). * Document, manage and maintain test records consistent with formal verification processes and Quality Management System policies and procedures. * 5 years of experience working in a similar role in class IIB medical device system verification This will require practical laboratory work and a technical background that enables you to have a solid understanding of the dialysis systems. * Lead the creation of Verification processes to support compliance with regulatory requirements related to data integrity and good documentation practice As System Verification Engineer you take a leading role in planning, preparing, executing and documenting verification, validation and usability tests during the development of new dialysis equipment. To accommodate our growth, we are looking for a dynamic, hands-on System Verification Engineer at Nipro Europe Group Companies (NEGC). * Document, manage and maintain test records consistent with formal verification processes and Quality Management System policies and procedures. * 5 years of experience working in a similar role in class IIB medical device system verification This will require practical laboratory work and a technical background that enables you to have a solid understanding of the dialysis systems. * Lead the creation of Verification processes to support compliance with regulatory requirements related to data integrity and good documentation practice
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System Technician

Nipro Europe Group Companies

Mechelen

To accommodate our growth, we are looking for a dynamic, hands-on System Technician at Nipro Europe Group Companies (NEGC). As System Technician, you will be supporting R&D product development and verification activities of new dialysis equipment. On top of this you will be a key member in the planning of test activities, building of test fixtures and measurement systems where necessary, and execution of tests related to design verification and investigations. You are part of the Medical Instrumentation Center (MIC) and report to the MIC System Engineering Manager. * Create and validate custom test fixtures and test systems needed for product design verification, integrating mechanical, electrical and hydraulic components. * Document, manage and maintain test records consistent with formal verification processes and Quality Management System policies and procedures. To accommodate our growth, we are looking for a dynamic, hands-on System Technician at Nipro Europe Group Companies (NEGC). As System Technician, you will be supporting R&D product development and verification activities of new dialysis equipment. On top of this you will be a key member in the planning of test activities, building of test fixtures and measurement systems where necessary, and execution of tests related to design verification and investigations. You are part of the Medical Instrumentation Center (MIC) and report to the MIC System Engineering Manager. * Create and validate custom test fixtures and test systems needed for product design verification, integrating mechanical, electrical and hydraulic components. * Document, manage and maintain test records consistent with formal verification processes and Quality Management System policies and procedures.
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GLP QA Manager

Real Staffing Brussels (International)

Beerse

The company is based in Beerse and is currently looking for a freelance / consultant GLP QA Manager. The GLP QA Manager will conduct supplier qualifications and risk assessments at third parties to check the qualifications for executing toxicological or bioanalytical testing. The GLP QA Manager will also be advising on quality incidents, deviations, CAPA's, ... related to the third party. Real Staffing Brussels (International) * Beerse * Freelance * Full Time - Real Staffing - Your responsibilities - For an international player in the pharmaceutical industry, I am looking for an experienced GLP professional. What am I looking for? * GLP (FDA part 58) * In a quality department * As a study director or study investigator * Conducting risk assessments and/or supplier qualifications * Fluent in English - This position can be 100% remote and executed from everywhere in Europe - Start date : ASAP - End date : end of the year The company is based in Beerse and is currently looking for a freelance / consultant GLP QA Manager. The GLP QA Manager will conduct supplier qualifications and risk assessments at third parties to check the qualifications for executing toxicological or bioanalytical testing. The GLP QA Manager will also be advising on quality incidents, deviations, CAPA's, ... related to the third party. Real Staffing Brussels (International) * Beerse * Freelance * Full Time - Real Staffing - Your responsibilities - For an international player in the pharmaceutical industry, I am looking for an experienced GLP professional. What am I looking for? * GLP (FDA part 58) * In a quality department * As a study director or study investigator * Conducting risk assessments and/or supplier qualifications * Fluent in English - This position can be 100% remote and executed from everywhere in Europe - Start date : ASAP - End date : end of the year
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Head Clinical Project Management

SGS Group Belgium

Mechelen

In the spirit of continued growth and to help improve our business, we are currently seeking for a Head Clinical Project Management. As Head Clinical Project Management (HCPM) (CPM) and ensure the allocation of the appropriate CPM resource to the projects. As HCPM, you may assume the responsibilities of a Project Manager in the management of clinical research projects. * Line management: managing and coaching the clinical project management team, providing them with support, advice and assistance, evaluating their training needs, organizing regular team meetings in order to control the execution of different projects (budget, planning, resources, quality, problems, …), performing annual appraisals and defining the performance objectives, … * Resource management: CO in the recruitment of new CPMs, evaluating the CPM workload, assigning a CPM to new projects, … In the spirit of continued growth and to help improve our business, we are currently seeking for a Head Clinical Project Management. As Head Clinical Project Management (HCPM) (CPM) and ensure the allocation of the appropriate CPM resource to the projects. As HCPM, you may assume the responsibilities of a Project Manager in the management of clinical research projects. * Line management: managing and coaching the clinical project management team, providing them with support, advice and assistance, evaluating their training needs, organizing regular team meetings in order to control the execution of different projects (budget, planning, resources, quality, problems, …), performing annual appraisals and defining the performance objectives, … * Resource management: CO in the recruitment of new CPMs, evaluating the CPM workload, assigning a CPM to new projects, …
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Data Expert - Master or PhD (Biomedical) Sciences

SGS Group Belgium

Mechelen

We have a challenge for a Secure Data Manager - Mechelen - The Secure Data Manager will be responsible for the transfer of unblinding data from and to the Secure Data Office and the cleaning of unblinding data within the Secure Data Office. These responsibilities encompass the creation of data transfer agreements, data cleaning documentation and the specification of edit checks and listings. The Secure Data Manager also performs the QC of unblinding data, the cleaning of the data in EDC and/or clinical database and the creation/follow-up of edit checks. In addition to the above mentioned activities, the Secure Data Manager will also be responsible for the handling of randomisation lists (upload of randomisation list in internal IWRS system, release of randomisation list at database lock, emergency unblindings, distribution of randomisation list to third parties,…). We have a challenge for a Secure Data Manager - Mechelen - The Secure Data Manager will be responsible for the transfer of unblinding data from and to the Secure Data Office and the cleaning of unblinding data within the Secure Data Office. These responsibilities encompass the creation of data transfer agreements, data cleaning documentation and the specification of edit checks and listings. The Secure Data Manager also performs the QC of unblinding data, the cleaning of the data in EDC and/or clinical database and the creation/follow-up of edit checks. In addition to the above mentioned activities, the Secure Data Manager will also be responsible for the handling of randomisation lists (upload of randomisation list in internal IWRS system, release of randomisation list at database lock, emergency unblindings, distribution of randomisation list to third parties,…).
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Quality Assurance Analyst

Jefferson Wells

BEERSE

The main responsibility of the Quality Assurance Analyst is to support the enhancements and upgrade of the eLIMS system. * 5+ years of related experience including at least one of the following: Quality Assurance, Quality Control, Analytical Testing, or IT, including experience working in pharmaceutical or other highly regulated industry * Ability to build and nurture strong, positive relationships with customers and partners in Global Quality Systems, PDMS, IT and other Quality functional groups required * Previous Quality Systems experience desirable - Through a personal follow-up, you receive quality support in every step that you accommodate. Jefferson Wells * BEERSE * Contract duration unspecified * Full Time The main responsibility of the Quality Assurance Analyst is to support the enhancements and upgrade of the eLIMS system. * 5+ years of related experience including at least one of the following: Quality Assurance, Quality Control, Analytical Testing, or IT, including experience working in pharmaceutical or other highly regulated industry * Ability to build and nurture strong, positive relationships with customers and partners in Global Quality Systems, PDMS, IT and other Quality functional groups required * Previous Quality Systems experience desirable - Through a personal follow-up, you receive quality support in every step that you accommodate. Jefferson Wells * BEERSE * Contract duration unspecified * Full Time
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EDC Validation Expert

SGS Group Belgium

Mechelen

The EDC Validation Expert makes the eCRF, IXRS and/or ePRO-tools fit for use and tests tool specifications through User Acceptance Testing, based on the clinical trial protocol and sponsor's requirements. * You would never like to stop learning, you have a great hunger for knowledge and are persistent to become the best EDC Validation Expert out there. Next to all the digital tasks, you will also provide expert guidance to the design and validation of EDC applications and you always and system providers throughout the whole process * Generate and maintain functional specifications for the EDC tool Data Validation Rules * Create test steps and validation documents for User Acceptance Testing of eCRF, IXRS and ePRO tools - SGS Group Belgium * Mechelen * Contract duration unspecified * Full Time - Company Description - At SGS, you can choose. First of all, out of our various vacancies. The EDC Validation Expert makes the eCRF, IXRS and/or ePRO-tools fit for use and tests tool specifications through User Acceptance Testing, based on the clinical trial protocol and sponsor's requirements. * You would never like to stop learning, you have a great hunger for knowledge and are persistent to become the best EDC Validation Expert out there. Next to all the digital tasks, you will also provide expert guidance to the design and validation of EDC applications and you always and system providers throughout the whole process * Generate and maintain functional specifications for the EDC tool Data Validation Rules * Create test steps and validation documents for User Acceptance Testing of eCRF, IXRS and ePRO tools - SGS Group Belgium * Mechelen * Contract duration unspecified * Full Time - Company Description - At SGS, you can choose. First of all, out of our various vacancies.
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SAS Programmer - Master Statistics

SGS Group Belgium

Mechelen

We have a challenge for a SAS Programmer / Master Statistics - Mechelen - You create, program and validate SAS datasets and you get the possibility to create randomisation lists. On the technical side you have knowledge of SAS (BASE-STAT-macros-…) in order to solve SAS programming errors, create SAS datasets, create and validate new SAS macros, create and document specifications / requirements of SAS datasets,… SGS Group Belgium * Mechelen * Not available * 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. We have a challenge for a SAS Programmer / Master Statistics - Mechelen - You create, program and validate SAS datasets and you get the possibility to create randomisation lists. On the technical side you have knowledge of SAS (BASE-STAT-macros-…) in order to solve SAS programming errors, create SAS datasets, create and validate new SAS macros, create and document specifications / requirements of SAS datasets,… SGS Group Belgium * Mechelen * Not available * 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.
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Master in Sciences - Clinical Data Manager

SGS Group Belgium

Mechelen

We are currently looking for Clinical Data Managers (Mechelen). You will be in charge of data cleaning of clinical subject databases. You check clinical databases on inconsistent, missing and incorrect data and make sure mistakes are found either way; 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. will define the cleaning package of a clinical trial; You will generate queries towards the sites to get the data clean and will not give up until you reach your goal; you love to communicate with all involved parties. You have obtained a Master's Degree in a paramedical area or biomedical sciences. SGS Group Belgium * Mechelen * Contract duration unspecified * Full Time We are currently looking for Clinical Data Managers (Mechelen). You will be in charge of data cleaning of clinical subject databases. You check clinical databases on inconsistent, missing and incorrect data and make sure mistakes are found either way; 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. will define the cleaning package of a clinical trial; You will generate queries towards the sites to get the data clean and will not give up until you reach your goal; you love to communicate with all involved parties. You have obtained a Master's Degree in a paramedical area or biomedical sciences. SGS Group Belgium * Mechelen * Contract duration unspecified * Full Time
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CMC Regulatory Affairs Responsible

Oxford Global Resources

Puurs

Oxford Global Resources * Puurs * Contract duration specified * Full Time - Your responsibilities - Do you have a solid experience in CMC Regulatory Affairs, and are you looking forward to a long-term mission with broad responsibilities ? At a global pharma company ? Then this is a great opportunity for you! Job Description - You will be CMC Regulatory Affairs responsible for one or more commercial and/or development small molecule compounds for all markets worldwide. Responsibilities * You will actively participate in several development and other teams * Post-approval CMC RA activities will include providing direction on the interpretation and application of global CMC regulations and guidelines for CMC changes including country specific requirements, defining regulatory strategy, writing CMC variation dossiers and coordinating responses to Health Authorities (HA). Oxford Global Resources * Puurs * Contract duration specified * Full Time - Your responsibilities - Do you have a solid experience in CMC Regulatory Affairs, and are you looking forward to a long-term mission with broad responsibilities ? At a global pharma company ? Then this is a great opportunity for you! Job Description - You will be CMC Regulatory Affairs responsible for one or more commercial and/or development small molecule compounds for all markets worldwide. Responsibilities * You will actively participate in several development and other teams * Post-approval CMC RA activities will include providing direction on the interpretation and application of global CMC regulations and guidelines for CMC changes including country specific requirements, defining regulatory strategy, writing CMC variation dossiers and coordinating responses to Health Authorities (HA).
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Tactical Planner

Oxford Global Resources

Puurs

The Tactical Planner Production Schedule for the tactical horizon (3/4-24 months) ensuring capacity & resources are in place to support agreed demand plan to satisfy the Customer requirements and to keep the inventory at the next handover point of the supply chain at the agreed target level. Oxford Global Resources * Puurs * Contract duration specified * Full Time - Your responsibilities - You have supply planning experience and are looking for a temporary assignment in the pharma industry ? You have strong communication and analytical skills ? You like tackling issues and solving them ? Then this may just be the right assignment for you! Project description - In essence the role is responsible for the service to customers ensuring the availability, in terms of date and quantity, of the shipping items to the next point of supply. Responsibilities - o Production volumes based on demand The Tactical Planner Production Schedule for the tactical horizon (3/4-24 months) ensuring capacity & resources are in place to support agreed demand plan to satisfy the Customer requirements and to keep the inventory at the next handover point of the supply chain at the agreed target level. Oxford Global Resources * Puurs * Contract duration specified * Full Time - Your responsibilities - You have supply planning experience and are looking for a temporary assignment in the pharma industry ? You have strong communication and analytical skills ? You like tackling issues and solving them ? Then this may just be the right assignment for you! Project description - In essence the role is responsible for the service to customers ensuring the availability, in terms of date and quantity, of the shipping items to the next point of supply. Responsibilities - o Production volumes based on demand
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R&D Scientist (Protein Science)

Jefferson Wells

Beerse

Experience in recombinant expression of proteins in various heterologous systems (E. coli bacteria, insect cells, mammalian cell lines, cell-free systems) is required. You have expertise in the purification of high-quality proteins using standard techniques and equipment (affinity, ion exchange, size exclusion chromatography via FPLC, SDS-PAGE, Westerns) is required. Expertise in protein characterization using techniques such as analytical gel filtration, mass spectrometry, dynamic light scattering, nano DSF, SPR is preferred. Knowledge of protein crystallization and structure determination is a plus. The Structural & Protein Sciences department is responsible for the delivery of proteins to enable assay development, HTS, pharmacological profiling and structural biology (X-ray crystallography, Cryo-EM and NMR). Experience in recombinant expression of proteins in various heterologous systems (E. coli bacteria, insect cells, mammalian cell lines, cell-free systems) is required. You have expertise in the purification of high-quality proteins using standard techniques and equipment (affinity, ion exchange, size exclusion chromatography via FPLC, SDS-PAGE, Westerns) is required. Expertise in protein characterization using techniques such as analytical gel filtration, mass spectrometry, dynamic light scattering, nano DSF, SPR is preferred. Knowledge of protein crystallization and structure determination is a plus. The Structural & Protein Sciences department is responsible for the delivery of proteins to enable assay development, HTS, pharmacological profiling and structural biology (X-ray crystallography, Cryo-EM and NMR).
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SAS Programmer - Master Statistics

SGS Group Belgium

Mechelen

We have a challenge for a SAS Programmer / Master Statistics - Mechelen - You create, program and validate SAS datasets and you get the possibility to create randomisation lists. On the technical side you have knowledge of SAS (BASE-STAT-macros-…) in order to solve SAS programming errors, create SAS datasets, create and validate new SAS macros, create and document specifications / requirements of SAS datasets,… SGS Group Belgium * Mechelen * Not available * 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. We have a challenge for a SAS Programmer / Master Statistics - Mechelen - You create, program and validate SAS datasets and you get the possibility to create randomisation lists. On the technical side you have knowledge of SAS (BASE-STAT-macros-…) in order to solve SAS programming errors, create SAS datasets, create and validate new SAS macros, create and document specifications / requirements of SAS datasets,… SGS Group Belgium * Mechelen * Not available * 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.
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