• Submission dossier for new product in IFDO and follow up them until getting MA.• Renewal all the MAs in timeline • Implementation and management of IFDO regulation in the company.• Develop professional relationship with IFDO staff • Responsible for product price and negotiation with IFDO• Responsible for closing contracts on GMP issues(Contract manufacturing and analysis, under licenses contract ,…) • Surveillance on purchasing raw material from valid… Show more • Submission dossier for new product in IFDO and follow up them until getting MA.• Renewal all the MAs in timeline • Implementation and management of IFDO regulation in the company.• Develop professional relationship with IFDO staff • Responsible for product price and negotiation with IFDO• Responsible for closing contracts on GMP issues(Contract manufacturing and analysis, under licenses contract ,…) • Surveillance on purchasing raw material from valid sources• Arrangement and participate in GMP inspection by IFDO• Conducting GMP training for employees in head office.• Surveillance on customer complain assessment department • Conducting GMP audit from various foreign and local supplier as lead auditor Show less

• Final release of medicine product to market• Handling GMP inspection from local and foreign authorities and companies.• Surveillance on conduction APR/PQR for the products.• Surveillance on quality audit activity including deviation handling and root cause analysis• Make final decision about non conformity products and customer complains• Conducting GMP training for manager and head of departments in factory• Conducting self inspection

• Surveillance on formulation, analysis and developing of new product• Surveillance on scale up of new product • Surveillance on trouble shouting of routine products • Surveillance on Conducting stability test according ICH regulation• Surveillance on preparation DMF in CTD format

• Surveillance on production of different kind of oral cephalosporin dosage forms like tablet, capsule, powder for oral suspension • Surveillance on production of sterile powder vial