Chemist – Quality Assurance

1 day ago

Roorkee UL IN Hercules Nutra Pvt. Ltd. Full time

Position Overview The QA Chemist is responsible for ensuring that all manufacturing activities documentation and quality processes comply with Indian regulatory requirements Schedule M CDSCO WHO-GMP cGMP The role involves reviewing batch records managing deviations overseeing in-process controls and ensuring data integrity and compliance throughout the manufacturing operations Key Responsibilities 1 Batch Documentation Quality Compliance Review Batch Manufacturing Records BMR and Batch Packaging Records BPR for completeness accuracy and compliance with SOPs Ensure all documents follow GDP Good Documentation Practices and ALCOA principles Coordinate for batch release by verifying QC results in-process checks and production compliance 2 In-Process Quality Assurance IPQA Carry out line clearance for dispensing manufacturing filling and packaging operations Conduct in-process checks such as weight variation hardness disintegration leak test pH labeling checks etc Monitor adherence to approved procedures and ensure compliance with cGMP Schedule M guidelines 3 Quality Systems Management Handle and update Change Controls Deviations CAPA Incidents and Market Complaints Maintain and revise SOPs BMRs and BPRs as per regulatory and operational requirements Participate in internal audits and support external audits State FDA CDSCO WHO client audits Ensure proper document archival and control through Document Control Systems 4 Validation Qualification Activities Assist in process validation cleaning validation equipment qualification and hold-time studies Review protocols and reports prepared as per WHO-GMP ICH guidelines 5 Training Compliance Monitoring Conduct and document GMP hygiene and documentation training for production and support staff Monitor shop floor practices to ensure adherence to hygiene safety and regulatory standards Support investigation of OOS OOT deviations and ensure timely implementation of CAPA 6 Coordination Cross-Functional Support Liaise with Production QC Warehouse and Engineering for smooth quality operations Ensure proper sampling of RM PM and timely coordination with QC for testing Verify dispensing activities and ensure correct material status labeling across the plant Skills Competencies Required Strong understanding of GMP WHO-GMP and Schedule M requirements Good knowledge of QA processes documentation and pharmaceutical manufacturing operations Excellent attention to detail and compliance-oriented mindset Strong communication skills and ability to enforce quality standards on the shop floor Ability to handle audits and regulatory inspections Qualification Experience Education B Sc M Sc in Chemistry Pharmaceutical Chemistry Microbiology or related field Experience 1-5 years in QA department of a WHO-GMP certified pharmaceutical or nutraceutical plant Freshers with good academic knowledge may also be considered Job Types Full-time Permanent Pay 18 000 00 - 30 000 00 per month Benefits Paid sick time Paid time off Provident Fund Work Location In person

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