Quality Developer

The ideal candidate for People in Science should have:

• Master/bachelor degree;
• 3 years experience in Quality Assurance/GMP pharmaceutical manufacturing;
• Percentage in service 100.

• Participate and prepare QA deliverables for new products/processes;
• Disposition of raw materials and intermediates;
• Prepare release dossier for APIs and drug product;
• Setting specifications for raw materials, intermediates and APIs, drug product and stability;
• Assessment of deviations and changes and regulatory support for CMC modules;
• Prepare Technical and Quality agreements with suppliers for supplier qualification;
• Expert QA role for CoEs (ADV, PDC, Tech Ops);
• Approve new suppliers;
• Ensure conformity of materials & products specifications;
• Support/develop and review/approve development reports, testplans, method validation, DRVs;
• Master batch records for Clinical Supply projects according procedures;
• Act as an SME for QA Biotech; .
• Participate in improvement projects (e.g. Quality By Design) to ensure Quality Assurance and Compliance according to Global Procedures and guidelines.

MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD is the name of Merck outside the US and Canada. MSD has a workforce of over 6.000 in the Netherlands at five different
sites. MSD is the largest pharmaceutical company in the Netherlands. It has large production facilities for Human Health and Animal Health in Oss, Haarlem and Boxmeer and R&D facilities in Boxmeer and Oss. The MSD Development Center in Oss (DCO) supports MSD’s need for product development activities, particularly for the emerging markets. The DCO is also involved in Product Value Enhancement and it supports MSD’s early phase clinical research in multiple therapeutic areas.

The Center of Excellence Biotech Technical Operations gives technical support, process support - troubleshooting and continuous improvement - to the local Biotech upstream and downstream Integrated Process Teams (operations), is involved by process fit / introduction of new processes in the production facilities and cooperates with other technical groups in the global network.Dit stukje hieronder