EDA Affairs Unit Head

About Minapharm 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. Minapharm employs a collective workforce of over than 1400 individuals & continues to expand their workforce with talented pool of Human Capital. Our Core Values: Diversity & Respect Integrity & Accountability Collaboration Leadership & Empowerment Innovation & Continuous Learning Responsibilities: Prepare EDA Visits and communicate with EDA inspector(S). Ensure compliance with regulations set by EDA. Prepare all documents and reports requested by the EDA. Prepare requirement to be ready on time; from QC Department in the Preparation of COAs and reference standards needed to be submitted with finished products samples to center lab NODCAR(&or) Bio - inn Follow with validation department the submitting of the first three batches for any newly registered product. Follow Raw Materials upcoming RMs and their documents to facilitate EDA release process. Archive all the registration documents, EDA reports, samples & COAs for products submitted to NODCAR (&/OR) Bio-Inn. follow all NODCAR (&/OR) Bio-Inn requirements for samples submitted to Central lab (EDA Prepare all requirements for EDA audits. Preparing a complete file for each product to contain all documents sent by Registration department & continuously update Perform any additional tasks as requested. Experience: 6-9 years of relevant experience. Education: Bachelor’s degree in pharmaceutical sciences. Show more Show less