Ahmed Eleaba

• Lead a team of QA professionals to manage and handle all QA activities around the facility.
• Maintain, monitor and continual improve of Quality Management system of the company.
• Responsible of QA budget.
• Ensure that all SOP are designed, reviewed and approved according to GMPc principles and company policy.
• responsible to ensure compliance with current Good manufacturing practices (cGMP) around the entire facility, Company standard Operating Procedures (SOPs), Good laboratory Practices (GLP), Good Storage Practices (GSP), Good Documentation Practices (GDP) and authority regulations and guidelines.
• Manage the batch release activities and make sure that all batches are manufactured and tested as per approved specifications.
• Mange and ensure effectiveness of document control activities ad date integrity performance
• Manage Quality Staff at site to assure knowledge and execution of site Quality System
• Approve The Site Master File and Validation Master Plan.
• Develop and approve the Quality policy and quality objectives
• Approve of Internal audit and External audit plan.
• Approve of Qualification, Validation and Calibration plans.
• Revise and approve the batch record.
• Manage and evaluate all trends of the following topics:

- Deviations and OOS

- Corrective and preventive actions

-Customer complaint and Recall

-Change management

• Manage and supervise all validation, qualification and calibration activities
• Manage and supervise all GMP compliance activities according to latest national and international GMP guidelines such as ( US-FDA, WHO, MHRA, EU-GMP and SFDA).
• Ensure the effectiveness of internal audit program.
• Ensure the effectiveness of supplier qualification program
• Ensures timely resolving of customer customer complaint and audit findings .
• To make sure integration quality risk management in all QMS elements.
• Establish and monitor plant Quality Metrics \ KPIs used to evaluate the effectiveness of the Quality System.
• Assure proper use of change management associated with validated processes.
• Conduct Management Review meetings wit company management to review the quality system performance.
• Ensure effectiveness of Product Quality Review and its outputs.
• Assure proper use of change management associated with validated processes.
• Make sure that the recall procedures are effective and efficient.

• Responsible of batch release activates according to SFDA authorities.
• Manage the internal audit program.
• Establish and manage supplier qualification and service provider program.
• Establish and mange the Quality Risk Management system and its application.
• Handle all external GMP audits coming from different authorities and SFDA audit.

• Supervise IPQA/GMPc team who carry out the detailed assessment of products and their components at different stages of manufacturing area.
• Establish a new IPQA department in dispensing, preparation and filling areas.
• Establish a new system to ensure GMP compliance in different stages during manufacturing area.
• Conduct an internal and external audits.

• Assist Quality Manager in all aspects of GMP compliance, QMS activities, IPQA activities and Batch Release.
• Approve all SOPs related to quality system and ensure the compliance with company policies and GMP guidelines.
• Lead and manage the team who responsible of Quality Management System activities such as : -

- Document Control System

- Deviation and quality defect investigation.

- Change Management System.

- Root cause analysis and CAPA System .

- Annual Product Review / Product Quality Review.

- Internal Audit (self Inspection) program.

- Quality Complaints and Product Recall.

-Risk Management System.

-Management Review.

• Handle all external GMP audits deferent authorities Such as ( WHO, GCC, MHRA and Egyptian MOH).
• supervise and manage supplier qualification and service provider program and related outsourcing activities
• Manage IPQA/GMP compliance team who carry out the detailed assessment of products and their components at different stages of manufacturing process.
• Responsible for managing and handling of external and third party audits
• Conduct an internal and external GMP audits.
• Lead the compliance committee.
• As a member in validation committee.
• as a member in Risk management committee.
• Review of quality policy and quality objectives.
• Review the site master file and validation master plan.
• Review of URS and Design specifications of new equipments and utilities.
• Review of validation and qualification protocols and reports.
• Review of validation, calibration and qualification plans.
• Review of internal and external audits plans.

• Supervise IPQA/GMPc team who carry out the detailed assessment of products and their components at different stages of manufacturing process
• Responsible of Quality Management System activities : -

- Document Control System

- Deviation, quality defect investigation and Root cause analysis.

- Change Management System.

- CAPA System .

- Annual Product Review / Product Quality Review.

- Internal Audit (self Inspection) program.

- Quality Complaints and Product Recall.

- Risk Management System.

• Responsible of Supplier qualification and service provider program and related outsourcing activities.
• Perform an external audit related to vendor audit of :-

- Raw materials and packaging materials suppliers.

(Performed On Site Audits on Many API Manufacturers in China).

-Toll manufacturing pharmaceutical companies.

• Issuing and updating all SOPs related to GMP and QMS to be on risk based.
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• Ensure compliance with current Good manufacturing practices (cGMP) around the entire facility, Company standard Operating Procedures (SOPs), Good laboratory Practices (GLP), Good Storage Practices (GSP), Good Documentation Practices (GDP) and authority regulations and guidelines.
• Double checking of all critical steps during manufacturing processes.
• Check the correctness and completeness of batch records.
• conduct line clearance activities.
• Participate in the quality failure investigations.
• conduct internal audit on different departments such as production, Warehouses, QC and Engineering.
• Coordinate validation activities between internal departments.
• Follow up of Qualification, Calibration and Maintenance plan for all equipments, Utilities and balances.