Farid Sayed Email & Phone Number

Giza, Al Jizah, Egypt

Giza, Al Jizah, Egypt

 Ensure that GMP standards are in compliance with the companyand regulatory standards Design and improve Quality Management systems and procedures Review and approve the SOP s, validation, qualification, protocols, annual product quality review, batch record, and manufacturing record. Quality Audit and Inspection Management Ensure adequate CAPA plans are established. Coaching and developing QA colleagues towards achieving high performance Managing all quality issues regarding investigations & complaints Coordinate &promptly perform any recall operation for medical pro ducts. Making sure that production processes meet international and national standards Monitoring performance by gathering relevant data and producing statistical reports Conduct Training & Development to QA Employees and Operational team to leverage the quality understanding to higher levels. Manages and maintains the Company’s quality inspection and product release programs for incoming and in-process materials and components, processes and finished goods. Sets Quality compliance objectives and ensures that targets are achieved. Building a qualification and validation system for equipment, machines, processes (Cleaning and manufacturing) and systems

Alexandria, Egypt

 Lead the company steering committee for FDA and WHO inspection andapproval project. Leading the technology transfer team to transfer the manufacturing processes of the new products (Sofosbuvir and Ravidasvir) including determination of the impurity control strategy, technology transfer agreements and protocols andmanufacturing process risk assessment. Manage all activities of the Quality Unit Including; Change Management,Deviation Management, CAPA Management, Documentation, Batch Records,micro & analytical labs, raw material, in-process , product testing and productrelease functions, reviewing and approving validation, stability and otherprotocols or reports as necessary. Manage the activities of the Quality Unit to assure the site is meetingperformance goals and adhering to the appropriate cGMPstandards. Keeps informed and current on new and pendingregulations to assuresustained site compliance Manage the technology transfer for new products Assures all required DMFs are prepared and updated as required. Building of Quality Management systems and procedures Conduct Training & Development to Quality staff and Operational team toleverage the quality understanding to higher levels. Manage internal, external and regulatory inspections Review / Approve Deviation and OOS investigations along with investigatingCustomer complaints and prepare appropriate responses Assure all validations are properly documented and performed, includingrevalidation. Recommend and assist with implementation of suggestions and changes toimprove the quality of products, plants, and the overall quality system. Meet all commitments generated by observations of regulatory agencies and audits. Setting of specifications for start materials, intermediates and finishedproducts. Ensure and follow up on implementation of corrective and preventive actions at the site.

Makkah, Saudi Arabia

 Manage all activities of the quality directorate (QC and QA) Including; Change Management, Deviation Management, CAPA Management, OOS, Documentation, Batch Records, micro & analytical labs, raw material, in- process , product testing and product release functions, reviewing and approving validation, stability and other protocols or reports as necessary. Manage the activities of the quality directorate to assure the site ismeeting performance goals and adhering to the appropriate cGMP standards. Manage the site risk assessment program Manage the introduction & technology transfer for new products (GlaxoSmithKline, Janssen, AbbVie, Merck, BioFarma) Building of Quality Management systems and procedures Conduct Training & Development to Quality staff and Operational team to leverage the quality understanding to higher levels. Manage supplier qualification inspections, internal, external andregulatory inspections (SFDA) Review / Approve Deviation and OOS investigations along with investigating Customer complaints and prepare appropriate responses Assure all validations are properly documented and performed, including revalidation. Recommend and assist with implementation of suggestions and changes to improve the quality of products, plants, and the overall quality system. Meet all commitments generated by observations of regulatory agencies and audits.

Giza, Al Jizah, Egypt

 Ensure that GMP standards are in compliance with the company and regulatory standards Design and improve Quality Management systems and procedures Review and approve the SOP s, validation, qualification, protocols, annual product quality review, batch record, and manufacturing record. Quality Audit and Inspection Management Ensure adequate CAPA plans are established. Coaching and developing QA colleagues towards achieving high performance Managing all quality issues regarding investigations & complaints Coordinate & promptly perform any recall operation for medical pro ducts. Making sure that production processes meet international and national standards Monitoring performance by gathering relevant data and producing statistical reports Conduct Training & Development to QA Employees and Operational team toleverage the quality understanding to higher levels. Manages and maintains the Company’s quality inspection and product releaseprograms for incoming and in-process materials and components, processes and finished goods. Sets Quality compliance objectives and ensures that targets are achieved. Building a qualification and validation system for equipment,machines, processes (Cleaning and manufacturing) and systems

Aleppo Governorate, Syria

 Creating/reviewing ASIA Pharmaceutical Industries quality management system according to FDA & EMEA standards including: Manage the Quality Department. Monitor quality systems in QC and maintain high analytical quality performance for the analysis of the marketed products to be in compliance with current (GMP/GLP) Assure that the facility layout designs are complying with Local and European regulatory requirements (e.g. New Solid Dosage forms Facility, New Sterile Facility, new Cephalosporin facility, new large parenteral volume facility, new ophthalmic products facility, new R&D Laboratories, new QC laboratories and new penicillin facility). Assure that deviation reports and the related corrective actions are complying with regulatory requirements Review and approve changes in the manufacturing process for all registered products. Participate in regulatory inspections/audits and responses thereto, as appropriate according to ASIA procedures. Provide and coordinate compliance and technical support for production and analytical problems. Review and approve all validation process protocols to ensure that it comply with the drug master files. Responsible for preparing monthly report for KPI for QC/QA department Responsible for preparation of registration files for foreign countries in the common technical document files format.

Badr City, Cairo, Egypt

 Creating/reviewing EIMC united pharmaceuticals quality control management system according to FDA & EMEA standards including: Directed all activities of the quality control department Responsible for all activities of Quality Control Department to ensure compliance with company, compendia and regulatory requirements Responsible for generation and update of specifications, procedures and SOPs Responsible for preparation of drug master file for the company’s products and all documents submitted to ministry of health which includes: Stability study protocols, Stability summary reports, Analytical method validation, Products composition sheets & new products application forms Responsible for registration of the company’s products in foreign countrieswhich includes: Tunisia,

Cairo, Egypt

Quality operations excellence projects Building NIR library

Giza, Al Jizah, Egypt

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