Quality Assurance Supervisor
Pharma Care KSA
Total years of experience :5 years, 5 Months
• Establish risk assessment studies relevant to the validation documentation.
• Responsible for Qualification of new facility and Equipment’s and Follow up overall validation activities
• Author, Review, execute process validation, Hold time Study protocols and validation summary reports.
• Author, Review, Execute Cleaning validation protocols and reports.
• Executed Qualification activities like IQ/OQ/PQ of all process related equipment’s.
• Perform validation testing and analyze data for validation documentation to determine acceptability.
• Responsible for ensuring and review of all calibration certificates in plant.
• Involved in assisting the QA Director, Quality Assurance to perform Quality Assurance Activities such as- Authors SOPs, Issuance, Distribution, Reviewing and controlling GMP documentation
• Responsible for training coordination as per training programmed Standard Operating Procedures
• Supervise and mange shop floor QA team for oral Powder & Liquid manufacturing areas
• Production oversight during validation events.
• Responsible for QMS throughout the plant and batch release system.
Implementation and follow up of the validation and qualification systems.
• Author, Review, execute process validation, Hold time Study protocols and validation summary reports.
• Author, Review, Execute Cleaning validation protocols and reports.
• Review analytical method validation and Participate in the deviations, OOS investigations and audits.
• Review calibration plans, follow its execution and issue balances calibration plans and execute them. • Machines and equipment qualification and requalification.
• Issue and maintain annual validation master plan and validation protocols.
• Review calibration certificates and follow up execution of calibration plans.
• Responsible for ensuring the availability of all items through new product initiation check list.
• Conducting regular investigations to guarantee that workers follow safety procedures as required • Conducting quality audits as required to ensure compliance with GMP, Quality standards.
• Handling the pharmaceutical tailing waste according to the set rules and procedures in this regard.
• Carrying out material sampling as needed to conduct QA audits, checking samples conformity and taking decisions (Batch Release) of samples acceptance
• Performing pre- and post-production quality checks and providing related reports.
• maintaining GMP in manufacturing by 21 CFR compliance in shop floor equipment’s.
• Ensuring compliance of plant conditions (Humidity, Temperature, ΔP) with set guidelines and inspection on the gowning.
• Checking machine conformity to standards as well as ensuring periodic maintenance implementation
• Performing batch release, ensuring line clearance and in-process checks in shop-floor activities.
• Ensure that GMP Standards are followed properly in the Warehouse, Dispensing and manufacturing areas and during the manufacturing processes.
• Note: I’m working at this time at: Solids area (Tablet, Capsule, powder Filling and Sachet) / Sterile area (Eye drops and WFI) / Syrup area, and also, in non-sterile penicillin area.
• Implementation and follow up of the validation and qualification systems.
• Author, Review, Execute Hold Time Study protocols and reports.
• Author, Review, Execute process validation protocols and validation summary reports.
• Author, Review, Execute Cleaning validation protocols and reports.
• Ensure the qualification for production machines / Lab equipment’s through conducting acceptance tests, installation qualification, operation qualification, performance qualification and requalification.
• Review analytical method validation.
• Review calibration plans, follow its execution and issue balances calibration plans and execute them. • Machines and equipment qualification and requalification.
• Issue and maintain annual validation master plan and validation protocols.
• Review calibration certificates and follow up execution of calibration plans.
• Participate in the deviations, OOS investigations and audits.
Graduated from Faculty of Science, Menoufia university (May 2017). • Bachelor of science (chemistry) department. • Cumulative grade: Very Good (honors).
