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Ankleshwar, India Zentiva Group, a.s. Full time

Job Description for Executive - Quality Assurance, PharmaEducational Qualification B. Pharm / M. Pharm from a reputed university Experience 1 to 4 years of similar experience in a regulatory-approved OSD manufacturing large unit. Quality Management/Continuous Improvement Line Clearance and shop floor compliance Assisting in the Complaint Investigation system at site Assisting in the Qualification and validation system, change control system, deviations Preparing & reviewing the Annual Product Quality Review Review of Batch Manufacturing & Packing Records Coordination of cGMP Training activity. Compliance Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by Understanding the requirements Performing the Gap analysis to find out the gaps in the existing system Preparing a compliance plan for the closure of gaps Execution of compliance plans Review of completion for compliance activity Validations & Qualifications: Ensure validated status of all equipment, manufacturing processes, and cleaning processes Review of protocols for qualification and validation of facility/equipment/product/process Review of validation reports after execution of validation of facility /equipment/product / process Documentation Control: Preparation and Review of SOPs Controlled distribution and archival of documents & record Control of master documents Assuring quality of products by : Ensuring SOP compliance Review of Batch Manufacturing & Packing Records Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints Ensuring the effectiveness review of the implemented CAPA cGMP Training : To prepare training modules and organize training in GMP Execute the training program in coordination with all concerned departments Other: Review of maintenance and calibration program