Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb, and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
Post : Associate Manager
Department : Quality Assurance - GLP
Job Description :
• Responsible for identifying and implementing necessary changes to develop a vision for the efficient functioning of the quality assurance function.
• Responsible for taking appropriate decisions whenever necessary without affecting quality and GMP aspects.
• Ensuring that the quality assurance aspects are completed appropriately and timely, including auditing, trend analysis, complaint review, and document review, maintaining compliance with clients and other regulations.
• Responsible for communicating quality aspects to clients effectively whenever necessary.
• Handling of customer projects and ensuring the documents related to Quality Control Microbiology are appropriately reviewed and approved.
• Assist QC department in developing appropriate corrective & preventive actions.
• Review of root cause investigations and subsequent CAPA to ensure and align with the quality system and regulatory compliance.
• Review and approval documents related to CSVC & overall qualification activity, protocols, reports, etc.
• Review and approve documents related to Qualification of systems, instruments, equipment, etc., generated by QC Microbiology and crosslinked departments.
• Being a part of the investigations. Review and approve deviations, Laboratory incidents, Out of calibrations, Out of specifications, CAPA, and Out of trend.
• Issuance of Documents (Annexures, ODS, Calibration sheets, Log sheets, etc.)
• Review and approval of deviations, Laboratory incidents coordinating in identifying the root cause investigations with CAPA approval.
• Responsible for handling, evaluating, and approving change control & adequate closure.
• Review & approval of specifications.
• Review and approve, SOP’s, protocols, Instrument operating procedures, IQ/OQ/PQ/DQ of all instruments of QC Microbiology.
• Be a part of self-inspection & conduct regular GMP rounds in the Quality Control Microbiology & Quality control biologics laboratory.
• Coordinating with the laboratory personnel in the handling of the customer queries
• Review of all the documents for adequacy concerning the principles of ALCOA+.
Candidate Profile :
M.Sc Microbiology / M.Pharma
Quality applications, QMS, CAPA, Report management
Minimum 12 years to 15 years
Presentation skills, Leadership skills, Communication skills, Report writing and Documentation.
Experience : 12 to 15 years
Qualification : M.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December, 2022
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