Senior Executive AM Quality Assurance Job At Amneal Pharmaceuticals
Amneal Pharmaceuticals is hiring experienced Quality Assurance professionals for its sterile manufacturing facility in Ahmedabad. This Executive Job role focuses on IPQA operations, including line clearance, batch document review, process validation, media fill, environmental monitoring, and ensuring complete cGMP compliance on the shop floor. If you have 2–7 years of relevant sterile IPQA experience, this opportunity is ideal for your career growth. Graduates seeking for B pharma jobs or M Pharma jobs can apply now.
Introduction of the Job
This Executive Job role requires hands-on sterile IPQA experience, including line clearance, documentation review, validation support, environmental monitoring, and ensuring cGMP adherence across cleanroom operations.
Job Details for Executive Job Role:
- Responsible for line clearance activity before dispensing, manufacturing, filling, inspection, sealing, labeling and packing
- Review executed BMRs and BPRs for batch release
- Handle process validation, cleaning validation/verification, hold time study, media fill and routine batch sampling as per protocol/SOP
- Perform in-process tests at different stages as per SOP and batch documents
- Review environmental monitoring and water trends
- Review planners and calibration certificates
- Review printouts such as CIP, SIP, autoclave, filter integrity
- Monitor cGMP compliance at shop floor
- Receive plates, samplers, swabs and other EM resources from microbiology lab, and hand them over back with filled formats
- Maintain issuance/reconciliation record of EM materials
- Conduct environmental monitoring of cleanroom manufacturing areas
- Participate in media fill simulation study
- Participate in qualification activities of manufacturing areas
- Perform non-viable particle monitoring as per schedule
- Conduct compressed air/nitrogen gas monitoring and personnel monitoring
- Perform aseptic behavior/practice monitoring for operators during each aseptic batch as per SOP
About the Company
This Executive Job position is based at Amneal Pharmaceuticals’ sterile injectable manufacturing site located in Pharmez Special Economic Zone (SEZ), Ahmedabad. The facility follows strict regulatory standards with advanced cleanroom operations to ensure high-quality sterile manufacturing.
Educational Requirements for Executive Job Role:
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B.Sc
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B.Pharma
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M.Sc
Experience Required:
- Total experience: 2–7 years
- Must be from IPQA Department of a sterile manufacturing plant
Key Responsibilities for Executive Job Role:
- Line clearance before all critical activities
- Executed BMR/BPR review for batch release
- Process validation and cleaning validation
- Participation in media fill
- Environmental monitoring & non-viable particle monitoring
- Qualification activities support
- Monitoring aseptic behavior and cleanroom discipline
- Ensuring cGMP, documentation, and shop floor compliance
Skills Required for Executive Job Role:
- Strong sterile IPQA experience
- Good understanding of EM and media fill
- Knowledge of qualification processes
- cGMP interpretation & compliance
- Documentation accuracy
- Aseptic practice monitoring and cleanroom discipline
How to Apply for Executive Job Role:
Graduates seeking for B pharma jobs or M Pharma jobs can apply now. Candidates can apply directly through the Amneal Pharmaceuticals official careers page by using the Apply Now option under Job ID 5023.