▷ (Apply in 3 Minutes) Microbiologist

2 weeks ago

Himatnagar GJ IN Dusons medicare Full time

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

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