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 : Junior Manager, IPQA (53085)
Department : Quality Assurance - Biologics
Job Description :
• Review of manufacturing documents (SOPs, EOPs, IOPs and Technology transfer documents) pertaining to Biologics function.
• Review of master batch records and executed batch records (BMR/PDR).
• Review of process validation, cleaning validation and hold time protocols/reports.
• Line clearance for batch to batch and product to product changeover.
• Ensure that good aseptic practices are followed inside the facility.
• Review of facility, process and EHSS risk assessment.
• Ensure readiness for internal and external audits by periodic GMP rounds.
• Issuance of logbooks and annexures for execution, review of executed logbooks and annexures.
• Responsible for Quality Assurance activities pertaining to Biologics manufacturing unit (In-process QA activities of Biologics Manufacturing Plants).
Candidate Profile :
• Master of Science / Master of Technology -Biotechnology / Bioprocess Engineering / Microbiology
• Knowledge on Biologics Manufacturing and testing compliance requirements.
• Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
• Clean room knowledge
• 7-9 years of experience in Biopharma manufacturing/testing/compliance/Quality Assurance.
• Aggressive but assertive on task completion.
• High influencing skills to complete the task at hand.
• Ability to provide solutions for complex problems.
• Eye for detail.
Experience : 7-9 years
Qualification : M.Tech, M.Sc
Location : Bangalore, Biocon Park
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th December, 2022
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