Lupin is a global pharmaceutical company offering Branded and Generic Formulations, Biosimilars and Active Pharmaceutical Ingredients (APIs). Founded over 50 years ago, Lupin today is a significant player in the US, India and Japan and additionally in other counties within APAC, EMEA and LATAM. It holds a global leadership position in Anti-TB and Cephalosporin segments.
Job Description: Greeting from Lupin Pharma Pvt. Ltd !!!
Important Details :
Roles & Responsibilities
• Review and approval of Quality System Documents monitoring of Quality system document such as deviation, change control, OOS, OOT, Market Complaint, Vendor complaint, CAPA, Risk assessment and Nonconformities.
• Review of microbiological data, TDS, Media preparation record, Autoclave cycle printout reconciliation of media and other reagent.
• Review and approval of Qualification documents and Validation documents for process Cleaning and Computer system etc.
• Ensure preparation and periodic review updating of Site Master File and Validation Master Plan. Review and approval of Annual Product Quality Review.
• Participation in aseptic process simulation and review of related documents and visual observations of Media fill vials.
• Review of executed BMR/BPR and responsible for batch release.
• Review of master documents such as e-BPR/BMR, specifications and STP’s and filter validation documents. Handling of Regulatory Audits and Customer audits.
Desired Candidate Profile
• Bachelor’s in pharmacy
• Pharmaceutical QA Sterile experience in USFDA / MHRA approved facility.
If above requirement matches with your profile kindly share the resume at parichayindore@lupin.com
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