QA Validation & Qualification Specialist

• Apr 2021 - Present

-Generate continued process verification reports to ensure products are in a validated state of control. -Generate validation protocols, risk assessments and all supportive data for processes validation for new products. -Establish production buffers and equipment hold time throughout the cycle of cleaning validation activity. -Perform 21 CFR 11 tests on new production and analytical equipment. -Follow up and monitor service suppliers during Different calibration and qualification processes ( IQ/OQ/PQ(HVAC, water stations compressed gases and pure steam) to ensure compliance of equipment and utilities to cGMP regulation. -Review Qualification documents (IQ/OQ) supplied by third parties for production and laboratories equipment. -Qualification of autoclaves , incubators, fridges,.. and generate the required reports. -Conduct and report all required reports for site validation. -Generate room data sheets for all production sites. -Establish traceability matrixes for new equipment using URS/ Equipment user manual and all relevant data. -Calibrate & generate calibration certificates for internal equipment (weighting balances/ ultra low freezers/ fridges ,freezers, HEPA filters). -Prepare, execute and report thermal mapping activities. -Receive and review calibration certificates from third parties to ensure the validity of certificates. -Update and issue the annual calibration plan covering all the equipment related to all departments( Production areas ,QC and microbiology laboratories). -Ensure integration of all validation/qualification & calibration schedules within production and laboratories schedule for implementation of all validation activities. -Prepare relevant cleaning validation reports. -Update Qualification/ validation SOPs. -Prepare risk assessment for relevant validation documents. -Generate deviations related to validation activities and participate in their investigations. -Conduct and follow change controls related to validation documents. Show less

Community Pharmacist

• Aug 2018 - Sep 2018