Vacancy for M.Pharm, M.Sc as Assistant Manager at Syngene International
Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities.
Post : Assistant Manager
• Qualification and re-qualification expertize related to Equipment, Instrument, Facility and Area
• Experience in Computer system validation in line with 21 CFR part 11 compliance, GAMP 5, ICH Q9 followed by EU Annex 11 related to all computerized systems.
• Expertize in Gap analysis related to Equipment/Facility/Systems
• Expertize in validation of the Critical utilities like Purified water system, WFI, PSG, Nitrogen and etc
• Experience in HVAC installations and validations followed by periodic re-validations
• Thorough knowledge in statistical analysis and different tools of risk management application
• Exposure in Temperature mapping activity of specific areas
• Review and evaluation of Change controls, Deviations and CAPA related to equipment, systems and facilities followed by having good presentation skills in training the CFTs
• Having very good knowledge in preparing SOPs, EOPs and exposure in review and approval of equipment master list, PM and Calibration planners.
• Expertize in carrying out investigations related to equipment and facilities
• Calibration document reviews and approvals
• Handling of SAP related activities which includes improvement and troubleshooting plans
• Exposure to Internal Audits, Customer Audits and Regulatory Audits which includes the preparation for audit, providing timely effective response for the same.
• Timeline conscious in delivering the requirements
• Experience in API/QC/Development lab facility is preferred.
• Expertise in best quality management system, preparing, reviewing and approving all the qualification documents, QMS documents, validation documents and any cGMP documents related to Chemical development and other areas
• To be well versed with CAPA, internal audit, vendor audit and the other cGMP activities.
• To be stationed at Mangalore and travel to Bangalore if needed.
• Education qualification might be with BE in computer Science or M.SC in CS or M.Pharm or equivalent having experience of
• Qualifications and requalification of Equipment/Facility/Systems, critical utilities like Purified water system, WFI, PSG, Nitrogen and etc followed by conducting the gap analysis for equipment/systems. Experience in Computer system validation in line with 21 CFR part 11 compliance, GAMP 5 and EU Annex 11 guidelines. Expertize in validation of HVAC installations and validations and exposure in Temperature mapping activity of specific areas
• Review and evaluation of Change controls/Deviations and CAPA related to equipment and facilities and expertize in carrying out investigations related to equipment and facilities if any
• Calibration document reviews, Expertize in Gap analysis related to Equipment/Facility/Systems and Knowledge in statistical analysis and risk management tools application and exposure to SAP is essential.
• To handle Service provider Audits and FAT, Exposure to Internal Audits, Customer Audits and Regulatory Audits and knowledge in Area Qualification and experience in API/Formulation/Biologics/QC/Viral testing facility is preferred.
Qualification : M.Pharm, M.Sc, B.E
Location : India
Industry Type : Pharma
Req Id : 4378
End Date : 30th April, 2019
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