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About this role
Job Opening: QMS - Quality Assurance (Sterile/Injectable Plant)
Department: Quality Assurance - Sterile
Location: As per business requirement
Experience: 3-8 Years
Industry: Pharmaceutical (Sterile/Injectable Manufacturing)
Key Responsibilities:
- Handling of Deviation, OOS, OOT, CAPA, Change Control, and Risk Assessment.
- Review and approval of quality system documents.
- Investigation and closure of quality events within timelines.
- Preparation, review, and maintenance of SOPs and quality records.
- Support regulatory inspections and customer audits.
- Trend analysis and monitoring of QMS metrics.
- Ensure compliance with cGMP, GDP, and regulatory requirements.
- Coordination with cross-functional teams for quality compliance activities.
Required Qualification:
- B.Pharm / M.Pharm / B.Sc / M.Sc or relevant life sciences qualification.
- Experience in sterile injectable manufacturing preferred.
- Good understanding of pharmaceutical quality systems and regulatory requirements.
Skills Required:
- Deviation Investigation
- CAPA Management
- OOS/OOT Handling
- Change Control
- Audit Compliance
- Documentation Review
- Root Cause Analysis
Interested candidates can send their updated CV to: [email removed]
Sourced from naukri
Skills
ootdeviationCAPAChange ControloosSterileInjectionInjectablesInvestigationQMSQuality Assurance
About Lupin

Lupin
Pharma
20.9k+
employees
1968
58 years old
Mumbai, Maharashtra
India
₹5L – ₹10L PA
This role
About
Global pharmaceutical leader, reporting over ₹20,000 crore in FY24 revenue and a leading global manufacturer of generic medicines with a product footprint in more than 100 countries.
Industries
PharmaBiotech & Life sciencesManufacturing
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