Abdullah Abu-Hafiza

Performing, monitoring, coordinating and following up on quality tasks while ensuring completion in an accurate, effective and timely manner and in compliance with set Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and guidelines, as well as:

• Conducting GMP audits in all departments pertain to quality system.

• Issuing QA SOPs and ensuring the system and SOPs are in compliance with Guidelines.

• Reviewing and approving technical departments SOPs.

• Carry out process deviation, and conduct the related investigation report.

• Review and evaluation of OOS/OOT and conduct the related investigations report.

• Reviewing and evaluation of change control request (CCRs), approval and set action plan.

• Perform CAPA management system including; CAPA issuance, follow up and CAPA effectiveness.

• Perform batch record review and approval for release.

• Perform reprocessing, reworking and recovery, and evaluate it results and similarity factor.

• Receive customer complaint, and conduct the related investigation report.

• Perform and review annual product quality review.

• Perform self inspection on the technical departments, and follow up on departments responses.

• Perform materials suppliers qualification, auditing and follow up on their responses.

• Perform supplier claim, and follow up with the supplier claim investigation.

• Hosting of authorities inspections, and follow up the required CAPA.

• Evaluation of Non-accepted results for retained samples.

• Reviewing and approving of manufacturing master formula/Instructions and master packaging formula/Instructions.

• Reviewing and approving products and materials specifications.

• Reviewing and approving of artwork and film sheet.

•Perform training and coached junior team members, fostering professional growth and improving overall team performance.

Performing QA tasks while ensuring completion in an accurate, effective and timely manner in accordance with set of Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and guidelines, as well as:

• Conducting GMP monitoring and auditing in production area.

• Perform approval for production rooms lineclearance.

• Checking machine conformity to standards as well as ensuring periodic maintenance implementation.

• Carrying out sampling, testing an evaluation of In process control test.

• Ensuring compliance of plant conditions (Humidity, Temperature, …etc) with set guidelines.

• Perform batch record review and approval for release.

• Carry out process deviations, and conduct the related investigation.

• Perform failure investigation reporting.

Performing QA tasks while ensuring completion in an accurate, effective and timely manner in accordance with set of Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and guidelines, as well as:

• Conducting GMP monitoring and auditing in production area.

• Conducting regular audits to guarantee that workers follow safety procedures as required .

• Perform approval for production rooms lineclearance.

• Handling the pharmaceutical tailing waste according to the set rules and procedures in this regard.

• Carrying out sampling, testing an evaluation of In process control test.

• Performing pre and post-production quality checks and tests and providing related reports accordingly.

• Ensuring compliance of plant conditions (Humidity, Temperature, …etc) with set guidelines.

• Checking machine conformity to standards as well as ensuring periodic maintenance implementation