On behalf of our client, one of the leading pharmaceutical companies focused on safeguarding individuals from cardiovascular diseases and pioneering innovative cancer treatments, we are currently looking for Qualified Person (m/f/d) for Clinical Trials in Bavaria
Key responsibilities:
* All activities corresponding to the role of a Qualified Person according to § 14 AMG, EU-GMP Guide Annex 16, Annex 13, and Clinical Trial Regulation (CTR) for clinical trial materials.
* Decision on the release or rejection of raw materials, packaging materials, intermediates, bulk products, and final packaged trial materials.
* Creation and approval of specifications and SOPs related to the release process of clinical trial materials.
* Review and approval of manufacturing and packaging documentation.
* Preparation, review, and approval of regulatory documents for clinical trials (IMPD, CMC section, QP Declaration, Master Label Approval).
* Review of pharmaceutical technical complaints regarding clinical trial materials.
* Preparation of QP declarations for the import authorization of pharmaceuticals according to § 72 AMG.
* Assessment of deviations, OOS, OOE, and OOT results, CAPA actions, and change control requests, including their review and approval.
* Determination of product shelf life based on stability data.
* Auditing of contract manufacturers, packagers, and laboratories.
Qualifications:
* Scientific degree, preferably in pharmacy, with several years of practical experience in drug development and testing, and extensive knowledge of pharmaceutical analytics, expertise according to §15 Abs. 1 AMG.
* Excellent English skills and intercultural competence due to various international interfaces.
* Organizational skills and leadership qualities for planning, organizing, and controlling employee deployment.
* Flexibility, resilience, independent and structured working style.
* Decision-making and problem-solving skills.
* Extensive experience in interpreting analytical stability data for determining product shelf life, several years of practical work in qualitative and quantitative analysis, and other quality tests of pharmaceuticals.
What's in it for you?
* An opportunity to make a tangible difference in patients' lives.
* Achieving this ambitious goal requires a collective effort, and the company values teamwork.
* The company fosters a culture of mutual respect and continuous learning, underpinned by diversity and inclusion.
* The chance to grow, think innovatively, and contribute your ideas.
Die Personalberatung SThree betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.