Samar Elsayed Email & Phone Number

Cairo, Egypt

Alexandria, Egypt

1. Assure that document control activities for all Pharco Corporation Companies are unified towards international standards & legal regulations. 2. Review, follow up issuance & distribution of corporate procedures & standards 3. Follow up the implementation of corporate procedures & standards with all corporate companies 4. Follow up the Issuance of corporate organograms & corporate job descriptions.5. Follow up of annual intercompany audit plan, prepare audit agenda & audit reports.6. Regular audit activities on corporate companies either on planned or unplanned basis.7. Follow up with QA managers CAPA plan submission for intercompany audit reports & CAPA fulfilment.8. Follow up ISO certification& training programs with Bureau Veritas for all Pharco Corporation Companies.9. Follow up the Communication with corporate training manager and preparation of annual & quarterly training plans.10. Prepare quarterly reports about the training plan implementation.11. Follow up creation& unification of electronic QMS systems in Pharco corporate companies

Alexandria, Egypt

• CAPA issuance & follow up for external inspections for regulatory agencies & toll companies for sterile & non sterile plants• Review & approve the annual product review reports• Prepare the Management review meeting& follow up the output action • Manage & control of all master documents, SOPs & Master batch production records• Compliance coordinator in the QMS committee for Pharco Corp

Alexandria, Egypt

• Manage the final product release activities for sterile & non sterile products

Alexandria, Egypt

• Initiate a system for Gap analysis• Prepare gap analysis reports against the updated guidelines for WHO, FDA, PIC/s& Eudralex • Follow up the implementation of action plans to close the gaps in QMS • Update the system of risk management according to PDA guidelines • Approve the change control reports (proposal & action plans) • Update the system of training & development according to WHO guidelines• Initiate & validate the change control & CAPA follow up software systems • Update the system for outsource activities• Participate in decontamination project for cephalosporin plant to be non cephalosporin.

Alexandria, Egypt

• Prepare annual plan for internal audit (self-inspection) & Manage implementation according the schedule • Manage the supplier Qualification system• Manage complain investigation & recall simulation activities• Follow up& training of GMP compliance staff in sterile & non sterile plants• Review Quality agreement for toll manufacturing companies• Review & approve Computer System Validation reports for all GXP systems

Alexandria, Egypt

• Master document & SOPs revision & issuance• Preparation of process and cleaning validation protocol & reports• Preparation of annual product review reports • Deviation investigation• Preparation of change control action plan• Issuance of Site Master File • Attend & prepare the CAPA report for the Romanian MOH inspection & compliance group inspection