QA Officer & Associate

De Bilt | Utrecht | Quality Assurance | GxP | GMP | CAPA | Validation | 1044030

Your new role

This role has a double function, in which, one, you are a Quality Assurance Officer, where you are responsible for the daily Quality Assurance support within the production location in De Bilt. You are the link between the operational production teams and the Qualified Person (QP). You are in charge of preparing the batch documentation for the QP. You ensure that the physical file is completely correct (including registration file, batch deviations, QC results). You provide direction on the floor regarding Good Manufacturing Practices (GMP) compliance. You are also involved in the design and implementation of qualification and validation activities, performing Root Cause Analysis and Change Control. You are responsible for the approval and release of equipment and production areas after (re)validation.
In addition to your work as a Quality Assurance Officer, you are responsible in the role of Quality Assurance Associate for reviewing production documentation and preparing the release proposal for the Qualified Person (QP) based on GMP and applicable country and product-specific laws and regulations. You work closely with fellow QA officer(s), QA associates and the QP to efficiently and effectively perform all core activities of Quality Assurance as a team. You report to the QA Lead De Bilt.

What you'll need to succeed

A completed and relevant HBO or WO education, preferably in Higher Laboratory Technology (HLO), Biochemistry or Microbiology. Preferably three years of relevant work experience within a production environment, preferably within the pharmaceutical industry. Preferably demonstrable work experience with deviation management, change management and process validation. Knowledge of GxP (good practice quality guidelines) methodologies. Fluent to professional proficiency of the Dutch and English language. Living at a passable distance from De Bilt and willing to travel to Boxmeer (about once a month) for consultation.

Your new company

MSD is a leading company in global biopharmaceuticals with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. With 69,000 employees operating in more than 140 countries, MSD offers state-of-the-art laboratories, plants and offices that are designed to inspire their employees as we learn, develop and grow.

The department Animal Health is located at the Boxmeer site. There they develop new medicines specifically for animals. They produce, amongst others, vaccines that prevent bacterial, parasitic and viral infections at both pet as farm animals. MSD is one of the first companies that focuses on biological research for animal health.

What you'll get in return

Hays Detachering | This is a project that will start with a contract for 9 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary and your travel expenses are covered.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1044030
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Life Sciences
Minimum Salary 4300 based on background + experience, Travel expense covered

Spreek met een consultant

Spreek met Ewa Tran, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Telefoonnummer: 0643452976

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