About this role
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.
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: