Job Description

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

Job Type: Full-time

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

Schedule:

Day shift
Work Location: In person