Highly skilled professionals with a passion for regulatory compliance are sought to fill a challenging role. This position offers an exceptional opportunity for individuals who are eager to contribute their expertise in ensuring the quality and safety of pharmaceutical products.
1. A highly experienced and qualified professional is required to oversee the certification process for batch release, adhering to relevant EC directives, including 2001/83/EC, Annex 16, and Annex 13 of the EU Guide to Good Manufacturing Practice, as well as Company Procedures.
2. The successful candidate will be responsible for verifying that batches have been manufactured and tested in accordance with current Good Manufacturing Practices (cGMP) and relevant marketing authorizations or clinical trial approvals.
3. In addition, they will manage deviations and laboratory investigations related to drug substance manufacture, testing, and any potential impact on product or material.
4. This role also involves reviewing and approving change requests with significant product impact, ensuring they have been thoroughly assessed, approved, and technically resolved.
Educational Requirements:
5. Bachelor's degree or higher in Biotechnology, Chemistry, Biology, or a relevant discipline.
6. EU Qualified Person (QP) qualification.
7. A minimum of five years of experience in certifying batches for release in accordance with relevant EC directives.
8. Demonstrated expertise in relevant GMPs, regulations, and current industry trends.