QA Executive
Bahrain Pharma
Total years of experience :12 years, 6 Months
Preparation of HVAC qualification protocols and co-ordinating with the engineering department for the successful execution of qualification activities.
Vendor evaluation for the procurement of raw materials and packaging materials.
Preparation and effective implementation of the approved SOPs in Engineering, Production and Quality assurance department.
Co-ordinating with the Engineering department for the preparation of IQ, OQ and PQ documents and for the effective installation of newly introduced equipments in the Production area.
Coordinate and conduct internal audit as per the audit plan.
Performing risk assessment for the systems and facilities having direct or indirect impact on product quality.
Responsible for Conduction training to all departments with respect to Quality Management System (QMS), Good Manufacturing Practice (GMP) etc.
Preparation of Batch manufacturing records, Process validation protocols and cleaning validation protocols.
Uploading of SOPs to EQMS through SAP, releasing the process order through SAP.
Co-ordinating for internal audit and the compilation of the same.
Performing risk assessment for the systems and facilities having direct or indirect impact on product quality.
Preparation and review of standard operating procedures.
Evaluate the new products and perform cleaning validation for the worst case product and compilation of the reports.
Coordinate and conduct internal audit as per the audit plan.
Responsible to coordinate with the internal departments to comply with the audit observations and to take necessary corrective & preventive actions if any.
Conduct trainings in coordination with the internal departments.
Evaluate the new products introduced into the facility and based on the evaluation, performing cleaning validation for the identified worst case products.
Performing process validation, hold time study and packaging validation activity for newly introduced product.
Coordinate and conduct internal audit as per the audit plan.
Performing risk assessment as per the guidelines for the manufacturing process / facility / system and co-ordinating with the concerned department HOD’s for the successful implementation of the same.
Performing IPQA activities in the Production and ensure that the respective activities are performed in compliance within the batch records.
Co-ordinating with the Engineering department for the preparation of IQ, OQ and PQ documents and for the effective installation of newly introduced equipments in the Production area.
Co-ordinating with engineering department for Performing HVAC validation and compressed air validation and for effective documentation of the validation activity.
Preparation and effective implementation of the approved SOPs in Engineering, Production and Quality assurance department.
Verification of the various activities in engineering department like facility maintenance, calibration activities and facility maintenance.
Performing IPQA activities in Production areas and report if any discrepancy to QA head.
Issuance, retrieval of controlled / data entry copy of master documents.
Performing calibration of IPQA equipments in the Production area.
Preparation and effective implementation of the approved SOPs in Engineering, Production and Quality assurance department.
Performing IPQA activities in Production areas and report if any discrepancy to QA head.
Issuance, retrieval of controlled / data entry copy of master documents.
Performing calibration of IPQA equipments in the Production area.
Preparation and effective implementation of the approved SOPs in Engineering, Production and Quality assurance department.