Quality Assurance Officer

3 weeks ago

Karad MH IN BRIX BIOPHARMA Full time

Quality Assurance Officer is responsible for ensuring that all manufacturing and quality-related activities comply with Good Manufacturing Practices GMP regulatory guidelines and company quality standards The role involves reviewing documentation monitoring production processes conducting internal audits and supporting continuous improvement to maintain product quality and regulatory compliance Key Responsibilities Review Batch Manufacturing Records BMR Batch Packing Records BPR and other related documents before batch release Monitor in-process activities in the production and packing areas to ensure compliance with GMP and SOPs Participate in line clearance in-process checks and documentation verification Review and ensure implementation of Standard Operating Procedures SOPs and update them as required Handle and document deviations change controls CAPA and OOS OOT investigations in coordination with relevant departments Conduct and support internal audits self-inspections and vendor audits to ensure compliance with quality standards Ensure the proper qualification and calibration of equipment instruments and utilities Participate in training programs and ensure proper documentation of staff training records Assist in validation and qualification activities process cleaning equipment and analytical methods Ensure data integrity and documentation accuracy in all QA operations Support preparation for regulatory and customer audits e g WHO USFDA MHRA GMP Promote a culture of continuous improvement and compliance within the organization Qualifications Experience Education B Pharm M Pharm M Sc Chemistry Microbiology Biotechnology or related field Experience Around 3 years of experience in Quality Assurance within a pharmaceutical formulation API sterile manufacturing unit Technical Skills Strong understanding of GMP GLP and regulatory requirements WHO USFDA EU-GMP Experience with documentation control CAPA change control and deviation handling Familiarity with validation and qualification protocols Soft Skills Excellent attention to detail and documentation accuracy Strong communication and coordination skills Ability to work cross-functionally with production QC and maintenance teams Good analytical and problem-solving skills Key Performance Indicators KPIs Timely review and approval of production and quality documents Number of deviations CAPA closed within target timelines Compliance rate during internal and external audits Reduction in documentation errors and non-conformities Adherence to GMP and company quality systems Job Type Full-time Pay 15 000 00 - 35 000 00 per month Benefits Paid sick time Paid time off Provident Fund Work Location In person

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