Mumbai Quality Assurance (Biotech Plant) Manager Opening

USV Limited
MUMBAI

Manager- Quality Assurance (Biotech Plant)
 
Job Description

Should have experience in managing the quality function of commercial manufacturing unit catering to India and Semi regulated markets
Team Leader and Team Player with good analytic and communication skills
Should be able to review QC reports and guide QC function for GMP compliance
Understand And Analyse Microbiology, immunology and bioassay analysis report
Experience in handling internal audits , CAPA , deviation, change control, OOS, OOT, investigations related to process and product failures, market complaints, etc.
Experience in handling Technology transfer and analytical method transfers from R&D to plant.
Should have hands on experience in conducting qualification of manufacturing and service equipment DQ/IQ/OQ/PQ
Should have experience in validating HVAC, Purified Water, WFI, Pure Stream, Process gases etc.
Should be well versed with process validations.
Minimum one-year exp in managerial function of manufacturing plant

Desired Profile

Candidate must have experience in Quality Assurance of Biotechnology Processes
Must have minimum 5 years experience in QA department of reputed biological industries working on recombinant therapeutic proteins
 
Experience 4 - 8 Years
 
Education UG - B.Sc,B.Tech/B.E. - Bio-Chemistry/Bio-Technology PG - M.Sc,M.Tech - Bio-Chemistry/Bio-Technology
 
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