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Job Code *902
Job Titile Assitt Manager QA
Company Client of VCS
Experience Min 5-10 Exp in Pharma
Location Bhopal
Detail Asstt QA Manager (Male/female) in pharma sector only Salary: up to 20000 – 25000kpm DIMENSONS OF THIS ROLE: - Review of Analytical / Inspection Specifications: Medication, Bulk, Packed Product and RM & PM. - Review of Master Batch Records: Medication & Bulk – BPR and PDR & report to Manager QA for Approval. - Notify the OOS and report to Manager QA. - Calibration of equipment: Review of annual calibration plan and make sure that lab should follow the same. - Responsible for preparing SOPs related to QA. - Responsible to review the finished product Certificate of Analysis as per accordance with the Australian Marketing Authorization/Other country marketing authorization requirements. - Responsible to review the all Quality Control documents like OOS, OOT, Deviations, Change controls, Validations and method transfer data, etc. - Responsible for Preparation of Documentation/ Implementation for Site Master File, Validation Master Plan, Quality Manual, Water Manual, On Job Training, Self-Inspection, MFCR, APQR, Validation and Qualification. - Responsible for Deviation/ Change Control/ Out Of Specification Completion of BMPR. - Review & Approve of Change control, Deviation, Nonconformance, OOS, OOT, Market complaints and investigation report. - Responsible for releasing of finished products as per approved specifications. - Responsible for all Document/ Process and Quality related work in Plant as per GMP norms. - Responsible for Self-Inspection audits, External Audit and Compliance. - Conduct Management review of all areas and Evaluation of documents. - Management of CAPA through APQR plan and Control of master documents. - Responsible to preparation of GMP related all documents. - To identify the training needs topics and organize training for developments. - Review and audit of micro-lab, QC-lab, Production area, engineering & utility, store & HR documents & areas. - Review and Responsible to maintain retention sample room records/ documents. - To conduct internal and external audits and to guide for compliance adherence. - Prepare SIP audit schedules and track action plan completion. - Responsible for tracking the consumer/customer and Regulatory complaints. - Responsible for tracking the Deviations and Change Control at the site. - Responsible for preparing Quality events (RM and FG) and forward to Manager QA/QC. - Responsible for preparing the validation (process) protocol, BPR’s and PDR’s. - Responsible for Mock recall exercise as per SOP. & forward to Manager QA. - Responsible for preparing annual product review for the products as per SOP & forward to Manager QA. - Responsible for handling


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