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. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.
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 MSC in CS or M.Pharm or equivalent having experience
• 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
End Date : 10th November, 2018
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