Microbiologist

**Job Summary**:Monitor trends in microbiological data and report deviations and out-of-specification results. Maintain, calibrate, and validate laboratory equipment according to SOPs. Review and approve microbiology-related documentation including SOPs, protocols, and test records. Assist in investigations for non-conformances and microbiological out-of-specification results. Participate in internal audits and support external audits and inspections. Maintain good documentation practices and ensure data integrity.

**Skills**:

- Oversee and maintain the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR Part 820, and other applicable regulatory standards.
- Lead and manage the QA team, including quality engineers, document control, and quality auditors.
- Ensure effective implementation of CAPA, non-conformance (NC), change control, deviation, and risk management systems.
- Support sterilization validation, equipment qualification, and product validation/verification processes.
- Manage internal and external audits, including FDA inspections, ISO audits, and customer audits.
- Develop, implement, and monitor quality policies, procedures, and training programs.
- Work cross-functionally with Manufacturing, R&D, Regulatory, and Supply Chain to ensure product quality throughout the lifecycle.
- Lead quality review boards (QRB), management reviews, and continuous improvement initiatives.
- Track and report key quality metrics (KPIs) to senior management.
- Review and approve quality-related documentation including batch records, protocols, and test results.

**Qualifications & Requirements**:

- Bachelor’s or Master’s degree in Microbiology, Biology, or related life sciences field.
- 2+ years of relevant QA microbiology experience in a medical device, pharmaceutical, or biotech manufacturing environment.
- Familiarity with aseptic techniques, environmental monitoring, and microbiological testing methods.
- Working knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP requirements.

**Working Conditions**:

- Standard working hours [9:00 AM - 6:00 PM]
- Potential for overtime based on production demands.

Experience = Fresher

Pay: ₹15,000.00 - ₹46,448.54 per month

Schedule:

- Day shift

Work Location: In person