Quality Assurance

1 day ago

Panvel MH IN Sisco Research Laboratories Pvt. Ltd. Full time

Job Summary We are looking for a detail-oriented and system-driven Quality Assurance QA professional to ensure organization-wide compliance with GMP GLP regulatory standards and internal SOPs This role involves cross-functional coordination with departments such as Production QC R D Raw Materials Finished Goods Maintenance and Projects Engineering to maintain quality systems and ensure audit readiness Key Responsibilities 1 Quality Control QC Review and approval of test methods specifications and SOPs Conduct audits focusing on data integrity and documentation practices Investigate and manage Out of Specification OOS results and CAPAs Ensure calibration and qualification of laboratory instruments 2 Production Approve Batch Manufacturing Records BMRs process-related SOPs and cleaning validation protocols Monitor adherence to cGMP during manufacturing operations Manage deviations change controls and the batch release process 3 Research Development R D Review and approve method validations and technology transfers Ensure GLP compliance and documentation traceability Audit R D processes for data integrity and regulatory readiness 4 Raw Material RM Approve material specifications and sampling plans Ensure proper vendor qualification and traceability of materials Authorize release or rejection of raw materials based on QC test results 5 Finished Goods FG Verify packaging and labeling compliance Approve finished product release post complete batch record review Ensure storage and dispatch practices adhere to GMP standards 6 Maintenance Ensure maintenance records preventive and breakdown meet GMP compliance Review the impact of breakdowns on quality-critical areas Approve equipment qualifications IQ OQ PQ and oversee calibration schedules 7 Projects Engineering Participate in Design Qualification DQ processes Review and approve equipment and facility validations IQ OQ PQ Ensure that utility systems HVAC water cleanrooms meet GMP requirements Manage change controls and conduct risk assessments during facility upgrades Conduct audits focusing on data integrity and documentation practices Investigate and manage Out of Specification OOS results and CAPAs Ensure calibration and qualification of laboratory instruments Requirements Bachelor s Master s degree in Pharmacy Chemistry Biotechnology or related field 1-5 years of QA experience in a pharmaceutical or biotech environment Strong knowledge of GMP GLP regulatory guidelines and quality systems Experience in audits documentation review and quality investigations Preferred Skills Good communication and coordination abilities Attention to detail and strong documentation skills Working knowledge of QMS software tools is a plus Job Types Full-time Permanent Pay 15 000 00 - 21 000 00 per month Benefits Provident Fund Work Location In person

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    1 week ago

    Panvel, India Caldic Full time

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  • Quality Assurance Supervisor

    1 week ago

    Panvel, India Caldic Full time

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    2 days ago

    Panvel, Maharashtra, India G. K. Associates Full time ₹ 2,00,000 - ₹ 6,00,000 per year

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    2 days ago

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    2 days ago

    Panvel, Maharashtra, India Sisco Research Laboratories Pvt. Ltd. Full time ₹ 1,89,000 - ₹ 2,52,000 per year

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