Job Description

REQUIREMENTSEducation / ExperienceEducation:Graduate / Post Graduate in Pharmacy or ChemistryExperience:2-3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirementsJOB PURPOSEGenericImplement Quality Assurance activities for Pharmaceutical at Ankleshwar adhering to standard operating procedures with optimum utilization of resources to ensure consistent good quality of products to meet with customers\xe2\x80\x99 requirements, living Group\xe2\x80\x99s Values and Code of Ethics.Specific additions (if needed)KEY ACCOUNTABILITIESQuality Management/Continuous ImprovementLine Clearance and shop floor complianceAssisting in Complaint Investigation system at siteAssisting in Qualification and validation system, change control system, deviationsPreparing & review 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 existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity Validations & Qualifications:Ensure validated status of all equipment\xe2\x80\x99s, 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 programIdentifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations

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