Clinical Trial Product Specialist
vor 21 Stunden
About the Job:
As a Clinical Trial Product Specialist at BioTalent, you will be responsible for ensuring the quality and compliance of clinical trial products. Your expertise in pharmaceutical regulations and clinical trials will be crucial in making informed decisions regarding the release or rejection of starting materials, packaging materials, and investigational medicinal products.
Key Responsibilities:
- Review and approve manufacturing and packaging documentation to ensure compliance with EU-GMP Guide Annex 16, Annex 13, and the Clinical Trial Regulation (CTR).
- Prepare and approve specifications, procedures (SOPs), and other regulations and documents related to the release process of clinical trial products.
- Review and approve documents for submission to regulatory authorities regarding the approval of clinical trials (IMPD, CMC section, QP Declaration, Master Label Approval).
- Evaluate deviations, OOS/OOE/OOT results, CAPA applications, and Change Control applications.
- Determine product shelf life based on stability data.
- Audit contract manufacturers, packagers, and contract laboratories.
Requirements:
- Scientific degree in Pharmacy or a related field and several years of experience in the development and testing of medicinal products.
- Extensive knowledge of pharmaceutical analytics and expertise according to §15 Abs. 1 AMG.
- Excellent English skills and intercultural competence.
- Organizational skills and leadership qualities.
- Decision-making and problem-solving competence.
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