At this moment, I am looking for a Lead QA & GDP compliance that fits the spirit of a well-established global Pharma & Medical Devices company aiming to accommodate new and evolving initiatives in ophthalmology.
In this role you’ll maintain the Quality Management System, support the QA related Distribution activities in EMEA and manage the subcontracted distribution activities. all in line with the GDP regulation.
- Implement and maintain the Quality System for the Netherlands aligned with EMEA
- Ensure that initial and continuous training programs are implemented
- Handle and approve distribution deviations, investigations, CAPAs and changes
- Support and conduct internal and external GDP/ GMP audits
- Be the point of contact for complaint handling
- Organize and document the Annual Quality Management Review
- Back-up the Responsible Person when required
- Act as the QA representative in the Supply Chain and Distribution projects
- Bachelor or higher degree (or equivalent) in Life Sciences, preferably Pharmacy
- At least 3 years’ experience in QA of Pharmaceuticals, preferably GDP related
- Experience as RP or QP is preferred
- Excellent English verbal and written skills
- Pro-active, strong communicator, open and transparent, independent and pragmatic
ORGANISATION AND OFFER
With 100+ years of investigative insight, the company remains committed to the discovery, exploration, and development of ophthalmic therapies. Now, and into the future. Their clinical development network now spans three continents, with centers in EMEA, Japan, and the US.
The organisation offers a competitive salary and benefits.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or email@example.com