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- Quality Assurance
About Our Client
Our client is a biopharmaceutical company that develops innovative, state-of-the-art products. They focus on research, development and further commercialisation of their products that provide a safer and more efficacious treatment of blood disorders. Furthermore, they are improving the survival and quality of life and addressing significant unmet medical needs.
As a QA Specialist you will be responsible for batch review (including all related documents), review and approval of deviations, change controls and associated documentation (CAPA, Qualification/Validation). You ensure that Quality policies, procedures and programs are properly implemented in daily GxP operations and remain up to date. You give advice to the Quality Control, Manufacturing, Clinical and Development departments internally and at 3rd parties regarding GxP compliance. For this position we are looking for an all-round QA Specialist who has extensive knowledge of GMP with the ability to interpret and apply in both routine and non-routine cases.
Responsibilities include but are not limited to:
- Ensure on time resolution deviation investigations and review (and approval) of changes;
- Perform review and approve deviation investigations;
- Participate in internal and external audits and projects;
- Support the organisation training initiatives and (improvement) projects;
- Maintain the internal Quality Systems and QA Archive.
The Successful Applicant
- Minimum of a Bachelor degree;
- Minimum of 4 years of relevant Quality Assurance or Manufacturing experience in (preferably) the (bio)pharmaceutical industry;
- Demonstrated experience with batch review, deviation investigations, change control, validation and/or audits;
- Self-motivated, excellent team player with strong communication skills;
- Fluent in Dutch and English (oral and written).
What's on Offer
Excellent primary and secondary benefits.