Ahmed Gaafer

- Ensure compliance with GMP pharmaceutical guidelines and ISO Standards.
- Initiating Quality Management System and Data Integrity at GYPTO PHARMA and qualification of the site for MOH licensing.
- Reviewing layouts, validation protocols and qualification studies.
- Initiation of Quality documentation system governing the site including SOPs, protocols, specifications, test methods, Batch records and Bill of materials.
- Initiation the in process control system for the non-sterile and sterile lines including SOPs preparation, IPC equipment purchasing and follow up of calibration and qualification activities.
- Supervision of vendor management / supplier evaluation system including raw/ packaging materials suppliers, toll manufacturers, Bio-equivalence centres and other service providers.
- Management of compliance activities in the site, including risk assessment of GMP related processes, deviation management & change control.

 Delegate of QA Manager.
 Management of supplier evaluation program & conduction of 2nd party audits to assess GMP compliance of suppliers, toll manufacturers & service providers.
 Reviewing the layouts of production departments, warehouses & QC labs (classes, differential pressure, material flow, personnel flow and airflow).
 Management of change control, product quality review, customer complaint & product recall.
 Review Deviation Investigation Reports from all departments to be evaluated and approved by Quality Assurance Manager.
 Creation and update of a plan for quality risk management in production areas, warehouses & Quality control, Ensure that all potential and existing quality risks are tracked, Review quality risk management reports to be evaluated and approved by Quality Assurance Manager.
 Management of CAPA system, ensure that all approved CAPAS are tracked and communicated to all concerned parties & manage the follow-up of CAPA plans implementation and effectiveness.
 Management & supervision of the documentation system including issuance, revision change & control of different documents like SOPs, protocols, test methods, procedures & others documents.
 Establish and update the major documents of Al Andalous for Pharmaceutical Industries like Site Master File, Company Manual, Quality Policy.
 Ensure compliance with ISO 9001, ISO 14001, ISO 18001, ISO 17025 & GMP pharmaceutical guidelines.

* IRCA certified lead auditor
* Supervise the organization of external audits from regulatory parties & licensors on EIPICO plant, Issuing corrective action plans for audit findings and follow up of CAPA programs.
* Management of internal audits pl Supervise the organization of external audits from regulatory parties & licensors on EIPICO plant, Issuing corrective action plans for audit findings and follow up of CAPA programs.
 Management of internal audits planning, selecting audit teams, review of the corrective action plan & final audit report.
 Participate in Quality risk management (planning & execution) in production areas, warehouses & Quality control.
 Supervise the change control system, review process change requests & annual list of the change control.
 Preparation of product quality review (PQR) reports, review the annual plan & review the executed annual product review reports.
 Supervise the planning & execution of on-job & refreshment training for staff & induction training of new employees in the R&D and Quality sector
 Participate in organization of management review meeting.
 Reviewing contracts & technical agreements between EIPICO and licensors or raw materials suppliers.
 Extensive knowledge of cGMP, FDA, WHO TRS, PICs, ICH & Eudralex guidelines regulations in Pharmaceutical Industries.
 Good knowledge of ISO 9001:2008 & ISO 14001:2004 & OHSAS 18001 clauses in Pharmaceutical Industries.
 Good knowledge of validation issues (process validation, equipment validation, IQ, OQ, PQ, cleaning validation & other validation process).
 Good knowledge of environmental monitoring issues.

 Perform routine analysis of raw material & finished products.
 Operation of the HPLC, UV spectrophotometry, Potentiometer, pH meter, Conductivity meter, Melting point, Disintegration tester, Hardness tester & Karl Fisher
 Prepare reagents and volumetric solutions.