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Pharmaceutical certification specialist

beBeeCertification
Biostatistician
Posted: 13 July
Offer description

Pharmaceutical Certification Opportunity - Hybrid Role

We are recruiting for an exciting opportunity in the pharmaceutical sector. This is an excellent position for individuals looking to join a leading multinational organization.

1. Broaden your expertise and contribute to certifying batches for release in accordance with relevant EC Directives, EU Guide to Good Manufacturing Practice, and Company Procedures.
2. Ensure batch manufacturing and testing align with current regulations and guidelines, identifying and escalating any potential concerns in a timely manner.
3. Provide oversight of deviations and laboratory investigations related to drug substance manufacture, testing, and potential effects on product or material.
4. Evaluate change requests with product impact, ensuring they have been appropriately reviewed, approved, and technically closed.

To excel in this role, you will require:

* A BSc degree (or higher) in Biotechnology, Chemistry, Biology, or a relevant discipline.
* EU QP Qualification
* 5 years of experience in certifying batches for release in accordance with relevant EC Directives, including 2001/83/EC, Annex 16, and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
* An expert level of knowledge of relevant GMPs, regulations, and current industry trends.

This is a fantastic opportunity to grow professionally and make a meaningful contribution to the success of our organization. We are committed to fostering a positive work environment that encourages collaboration, innovation, and excellence.

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