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Job Code *928
Job Titile Sr.QA/Asitt Manager-QA
Company Client of VCS
Experience Min 5-10 Exp in Pharma
Location Bhopal
Detail QA EXECUTIVE (FROM PHARMA BACKGROUND ONLY) Sal -20-25k 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. - Prepare SIP audit schedules and track action plan completion. - Responsible for review of Raw and Packing Material, Bulk and FG Specifications. - 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 of product/process/packaging validation & forward to Manager QA for approval. - Responsible for the equipment validation as per validation master plan. - Responsible for updating the PQM data. - Responsible for updating Quality score card. - Responsible for receiving and reviewing the technical standards. - Responsible for distribution of relevant technical standards to QC. - Responsible for updating RM/PM approved supplier list and distributing the same to Warehouse and QC. . KEY RESPONSIBILITIES: Control Function: Inspection of in-process materials. Technical Function: Documentation Control (SOP’s), Preparation of QA SOP’s and reviews of Protocols, specifications and master production records and process/product validation. Compliance Function: Responsible to carry out investigation for consumer/customer complaints and non compliances etc. KEY BEHAVIOURAL COMPETENCIES REQUIRED: - Leadership skills - Communication skills - Technical Knowledge - Decision making - Managerial skills - Analytical skills - People Management - Planning skills EXPERIENCE/KNOWELDGE/TECHNICAL SKILLS REQUIRED: 3 to 5 yrs – at least 2 yrs in senior levels in Quality Assurance at Pharmaceutical Companies. Post Graduate Professional Qualification like M.Sc. M. Pharm or PhD. MS Office-Familiar with Excel, Word, Power point


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