QA Section Head - Document Control At Minapharm Pharmaceuticals
Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline. Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO, Minapharm has established an integrated business model making it the only gene-to-market company in the region. Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, has incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.
Diversity & Respect
Integrity & Accountability
Leadership & Empowerment
Innovation & Continuous Learning
Oversee all document control activities.
Duties and responsibilities:
Prepare, review and implement different document control SOPs.
Prepare site master file and review it periodically & after changes.
Review all quality documents such as procedures, work instructions, specifications, test methods… etc.
Manage controlled distribution, withdrawal, archival and destruction of documents.
Monitor, evaluate, coach and develop document control employees.
Participate in different multidisciplinary teams and relevant activities as required.
Lead, coach & develop subordinates.
6+ years of experience in pharmaceutical industry including experience in quality assurance document control.
BSc in pharmaceutical sciences or relevant discipline.
Training in WHO & EU GMP guidelines.