 Regular review of regulatory documents with technical data to be aligned with regulatory authorities’ requirements. Review documents generated by other departments for registration and re-registration purposes Act as contact person in the site to deal with EDA inspector in all Quality and regulatory activities and site contact person with LOC Regulatory Affairs. Responsible for ensuring smooth sealing of all APIs and imported bulks by the EDA inspector and ensure their sealing… Show more  Regular review of regulatory documents with technical data to be aligned with regulatory authorities’ requirements. Review documents generated by other departments for registration and re-registration purposes Act as contact person in the site to deal with EDA inspector in all Quality and regulatory activities and site contact person with LOC Regulatory Affairs. Responsible for ensuring smooth sealing of all APIs and imported bulks by the EDA inspector and ensure their sealing before releasing them to the production. EDA weekly visits: NODCAR, EDA reference lab, EDA stability department, EDA Inspection. Opex management for EDA fees  Responsible for handling rejected finished goods, raw material or bulk disposal submitted by warehouse to the EDA for verification and approval. Coordinate with the Production/Quality department to provide the EDA or NODCAR with the required information and documents. Manage retain of parallel samples till NODCAR compliance received. Prepare registration dossiers for local and export markets and maintain good archiving system. Prepare & submit NODCAR inspection for finished goods & Raw materials, as per EDA guidelines. Prepare and update product specifications and maintain their regular review. Prepare and Submit renewal & registration packages for export (dossiers, POA, declarations, samples, CPP, GMP, MOH applications. …etc.) Prepare variations and updating registration data following regulatory changes and CCR actions. Issue and control certificates of pharmaceutical product (CPP) and GMP certificates to accomplish registration in export and follow up their legalization after evaluation and revision by the authorities: Ministry of Health, Ministry of Foreign Affairs, embassies…etc. Prepare registration dossiers for addition of suppliers to MA. Fulfill regulatory authorities’ requirements (Post approvals, renewal requirements, new Guidelines…etc.) Conduct Self inspections. Show less

- Carry out validation for analytical methods as per validation protocols and reports results in the due date according to approved protocols and specifications with the preparation and updating of relevant documentations.- Calibrate analytical lab equipments and instruments according to approved SOPs e.g. HPLC, GC, UV/Vis, IR and Atomic Absorption Spectrophotometer, balances and other analytical instruments.- Ensure that EHS requirements are fulfilled during work.- Implement and… Show more - Carry out validation for analytical methods as per validation protocols and reports results in the due date according to approved protocols and specifications with the preparation and updating of relevant documentations.- Calibrate analytical lab equipments and instruments according to approved SOPs e.g. HPLC, GC, UV/Vis, IR and Atomic Absorption Spectrophotometer, balances and other analytical instruments.- Ensure that EHS requirements are fulfilled during work.- Implement and maintain GMP and GLP requirements..- Support launching of new products by fulfilling all MOH requirements relevant to method of analysis.- Prepare and update SOP’s of different analytical functions.- Perform Technical Investigation for any raised Out Of Specification related to the method of analysis or equipment breakdowns.- Participate in self inspection activities and support in lab maintenance activities.- Support GPS "GSK Production System" implementation in managing different activities relevant to the role.- Perform In-Vitro studies according to MOH requirements.- Perform Method transfer for new products. Show less

Responsible for receiving and analyzing different forms of pharmaceutical products (aerosols, tablets, capsules, ointments, suppositories, syrups, and ampules) through their manufacturing processes (In-process controls and finished products)/and their stability studies, under specific procedures, protocols and conditions guided by Standard Operating Procedures (SOPs).

Responsible for receiving and analyzing different forms of pharmaceutical products (aerosols, tablets, capsules, ointments, suppositories, syrups, and ampules) through their manufacturing processes (In-process controls and finished products) under specific procedures and conditions guided by Standard Operating Procedures (SOPs).