Description:

Responsible for overseeing and executing microbiology laboratory activities, including microbiological testing, water analysis, environmental monitoring, method validation, equipment qualification, and laboratory documentation. Ensure compliance with GMP, GLP, data integrity, pharmacopoeial, and regulatory requirements.

Essential Functions:

- Perform microbiological testing of finished products, stability samples, water, and utilities.
- Conduct environmental monitoring of laboratory and production areas.
- Perform microbiological method validation/verification and equipment qualification.
- Prepare and review SOPs, STPs, specifications, protocols, and laboratory records.
- Ensure compliance with GMP, GLP, data integrity, and regulatory requirements.
- Review analytical data,



LIMS records, and audit trails for accuracy and compliance.
- Support internal, customer, and regulatory audits, investigations, and CAPA.
- Monitor laboratory resources, housekeeping, hygiene, safety, and consumables.
- Train and assess microbiology personnel for competency.
- Ensure laboratory operations remain audit-ready and support continuous improvement.

Qualifications

Education:

- Bachelors Degree (BA/BS) B. Sc.
- Required

- Master Degree (MS/MA) M. Sc.
- Preferred

Experience:

- 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

📌 Senior Executive, Quality Control (Gujarat)
🏢 Amneal
📍 Gujarat