Quality Assurance Job at Amneal Pharmaceuticals | Microbiology | Apply Now
Amneal Pharmaceuticals is seeking a highly skilled Senior Officer for QA Environment Monitoring at their Sanand facility in Ahmedabad. This Quality Assurance Job is a vital role within the sterile manufacturing plant, focused on ensuring rigorous cGMP compliance and environmental integrity. If you are a microbiology professional looking to advance your Amneal career, this position offers a specialized platform to lead environmental monitoring (EM) activities and aseptic process simulations in a high-compliance environment.
- Job Position: Senior Officer, QA Environment Monitoring
- Location: Ahmedabad City, Gujarat, India
About the Company
Amneal Pharmaceuticals is a leading global pharmaceutical company dedicated to the development and manufacturing of high-quality medicinal products. With a state-of-the-art sterile manufacturing plant located in Sanand, Ahmedabad, the company serves as a critical hub for complex pharmaceutical operations. An Amneal career offers professionals the opportunity to work in a high-compliance environment where technical excellence and scientific integrity are the primary drivers of success.
Job Overview
The Senior Officer is responsible for the end-to-end oversight of the manufacturing environment and sterile processes.
- Operational Oversight: Perform line clearance activities before commencing dispensing, manufacturing, filling, inspection, and packing operations.
- Environmental Monitoring: Conduct routine EM and non-viable particle monitoring of clean room areas according to defined schedules.
- Specialized Monitoring: Execute compressed air, nitrogen gas, and personnel monitoring to ensure total sterile control.
- Validation & Simulation: Lead process validation, cleaning verification, hold time studies, and participate in media fill simulation studies.
- Documentation Review: Review executed BMRs/BPRs, water trends, calibration certificates, and technical printouts such as CIP, SIP, and autoclave records.
- Resource Management: Manage the issuance, reconciliation, and handover of EM materials like plates and swabs to the microbiology lab.
Key Responsibilities
To excel in this Quality Assurance Job, candidates must demonstrate proficiency across several technical domains:
- Environmental Monitoring (EM): Expert-level knowledge in routine and qualification monitoring.
- Aseptic Process Simulation: Expert-level skills in Media Fill monitoring and review of simulation records.
- In-Process Quality Controls (IPQC): Practitioner-level ability to perform tests and sampling at various stages.
- Line Clearance & Batch Review: Practitioner-level experience in BMR/BPR review and shop floor compliance.
- Documentation & Regulatory: Practitioner-level understanding of Good Documentation Practices (GDP) and cGMP regulations.
Eligibility & Requirements
This Microbiology Job requires specific academic backgrounds and hands-on experience in sterile facilities.
- Education: B.Sc. or M.Sc. in Microbiology.
- Experience: 1 to 6 years of experience specifically in Environmental Monitoring within a sterile manufacturing plant.
- Internal Candidates: Must have completed at least 2 years in their current role at Amneal.
- Apply Before: February 27, 2026, 01:45 PM
Securing this Quality Assurance Job at Amneal Pharmaceuticals is a definitive step toward a high-growth career in sterile manufacturing. This Microbiology Job provides the opportunity to master complex aseptic protocols and environmental trend analysis while working at a premier facility in Sanand. If you have the required 1–6 years of EM experience, ensure your application for Job ID 7258 is submitted before the February 27th deadline to be part of an elite team dedicated to pharmaceutical excellence.
