Key Deliverables:   - Carry out gap analysis against guideline for SOP on CAPA, OOS, and OOT and revise SOP if required to further enhance the system.   - Train the people and implement the system at respective sites December 2014  - Make a monthly plan for data review and complete the review as per plan, prepare laboratory incident report or OOS report as applicable  - Do the gap analysis of the current systems with ICH Q7A, 21 CFR & other EU/US guideline to further enhance system. Prepare gap analysis report every month in QA  - Carry out gap analysis against applicable regulatory guidelines and industry standards in all GMP areas (other than QA/QC) at respective plants. Review and approve gap analysis report every month.  - Bridge the gap by revision of QMS documents, training and monitoring the system. Prepare reports every month.  - All regulatory and customer audit to be cleared without critical observation by this way.   - Initiate strategy for QMS automation.  - Strengthening of Laboratory investigations and OOS investigations and closure of OOS within stipulated timeframe.  - Review documents such as MPR, BPR, Analytical protocols,standard test procedures, specification as per pharmacopoeia or regulatory requirements.  - Review completed batch - production and lab control records before release for distribution.  - Review & approve finished product COA.  - Plan & conduct internal audit.  - Review annual product quality review  - Prepare & review validation protocols and reports.  - Handle change control & deviation activity  - Review OOS, complaint, rejected & returned product report.  - Review stability data to support retest or expiry date.  - Performing cGMP audits & ensuring compliance  - Handling regulatory & customer audits  - Making sure OOS,OOT & deviations are performed  - Approving changes that potentially affect Intermediate & Finished API quality  - Reviewing & approving SOPS, specification,batch manufacturing records(BMR) & other master documents  - Imparting training on cGMP & ensuring effective training programme is available for new & existing employees for all relevant departments  - Qualifying vendors for raw materials & packing materials as per defined procedure  - Handling complaints, returns & recalls. Making sure investigations are performed & CAPA implementation  - Releasing & rejecting finished APIs & intermediates  - Performing quality risk management related to instruments, equipment, documents, process,etc  - Reviewing completed batch production & analytical records release of finished API for distribution along with SAP controls  - Making sure that effective systems are available for document control  - Approving contract manufacturing including contract laboratories  - Reviewing & approving validation & qualification documents  - Making sure that effective systems are available for maintaining & calibration of critical equipment & instruments  - Making sure that there is stability data to support retest or expiry period & storage conditions for finished products & intermediates  - Reviewing & approving annual product quality reviews  - Coordinating with Regulatory department & supporting Regulatory compliance  - Reviewing & approving Technology Transfer documents

Mumbai

Senior Manager/Chief Manager - Quality Assurance - Healthcare/Pharma 

Senior Manager/Chief Manager - Quality Assurance - Healthcare/Pharma  ,Job Description for Senior Manager/Chief Manager - Quality Assurance - Healthcare/Pharma  in Menschen in  Mumbai for (12-18) years of experience. Apply Now!

Job Description for Senior Manager/Chief Manager - Quality Assurance - Healthcare/Pharma  in Menschen in  Mumbai for (12-18) years of experience. Apply Now!