Shantha Biologics A leader in vaccine development and injectables, originated from Shantha Biotechnics — India’s first company to develop a recombinant human healthcare product. Since 1993 the site has been dedicated to delivering affordable healthcare solutions, with a strong focus on vaccines and sterile injectable products. Our mission is rooted in innovation, quality, and equitable global access to essential biologics.
Shantha Biologics Hiring
Assistant Manager – QA Validation
Experience : 9–13 Years
Qualification :
• M.Pharm / M.Sc. (Relevant Life Sciences Discipline)
• Experience in equipment, utility, CSV, filling line and isolator qualification.
• Strong understanding of cGMP, Annex 1 and regulatory inspections (USFDA/EMA).
Key Responsibilities :
• Execute and review qualification/validation activities (IQ/OQ/PQ) for equipment, utilities, filling lines, isolators and AV systems.
• Manage validation lifecycle activities, including risk assessments, deviations, CAPAs, change controls and validation documentation.
• Support process, cleaning and computerized system validation and act as validation SME during audits.
Sr. Executive – IPQA / IPQC
Experience : 5–8 Years in IPQA/IPQC within Biopharmaceutical Manufacturing
Qualification :
• B.Pharm / M.Pharm / M.Sc. in Related Discipline
Key Responsibilities :
• Line Clearance & In-Process Checks.
• Review BMRs, BPRs and Analytical Testing Records.
• Handle deviations, OOS and OOT investigations, change controls & investigations.
• Conduct shop-floor training & provide audit support.
Sr. Executive – IPQM
Experience : 5–8 Years in Biopharmaceutical Manufacturing
Qualification :
• B.Pharm / M.Pharm / M.Sc. in Microbiology, Biotechnology, Chemistry or Related Field
Key Responsibilities :
• Review Microbiology Records & BET Results.
• Verify Environmental & Utility Monitoring.
• Lead OOS/OOT & Contamination Investigations with CAPA.
• Support Sterility Assurance & Aseptic Monitoring.
Location : Muppireddipally, Hyderabad
Apply Here Email : hra@shanthabiologics.com
Assistant Manager – QA Validation : Apply Online
Sr. Executive – IPQA / IPQC : Apply Online
Sr. Executive – IPQM : Apply Online
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