Executive - Quality Assurance, Pharma

2 days ago

ankleshwar, India Zentiva Full time

Job Description for Executive - Quality Assurance, PharmaEducational Qualification B. Pharm / M. Pharm from a reputed universityExperience 1 to 4 years of similar experience in a regulatory-approved OSD manufacturing large unit.Quality Management/Continuous ImprovementLine Clearance and shop floor complianceAssisting in the Complaint Investigation system at siteAssisting in the Qualification and validation system, change control system, deviationsPreparing & reviewing the Annual Product Quality ReviewReview of Batch Manufacturing & Packing RecordsCoordination of cGMP Training activity.ComplianceEnsure adherence to company Quality Standards, Local FDA MHRA regulations, byUnderstanding 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 processesReview of protocols for qualification and validation of facility/equipment/product/processReview of validation reports after execution of validation of facility /equipment/product / processDocumentation Control:Preparation and Review of SOPsControlled distribution and archival of documents & recordControl of master documentsAssuring quality of products by :Ensuring SOP complianceReview of Batch Manufacturing & Packing RecordsEnsuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaintsEnsuring the effectiveness review of the implemented CAPAcGMP Training:To prepare training modules and organize training in GMPExecute the training program in coordination with all concerned departmentsOther:Review of maintenance and calibration program

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