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
