Executive - Quality Control

As an Assistant Manager - Quality Control at Bharuch SEZ, you will play a crucial role in ensuring compliance with global regulatory requirements such as 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, and HACCP. Your responsibilities will involve regularizing QC activities as per cGMP requirements, ensuring lab compliance with regulatory and Pharmacopeia requirements, reviewing hybrid and electronic data for IPQC & FG analysis, conducting analytical method validation, OOS & OOT, and demonstrating knowledge of IMS system standards. Key Responsibilities: - Regularize the QC activities as per cGMP requirements. - Ensure compliance with regulatory and Pharmacopeia requirements for lab. - Review hybrid and electronic data for IPQC & FG analysis. - Conduct analytical method validation, OOS & OOT. - Demonstrate knowledge of IMS system standards. - Utilize analytical skills for QC instruments such as GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point, etc. - Coordinate with QC staff, R&D, Commercial, and Production for quality and dispatch related activities. - Resolve troubleshooting related to QC activities. - Provide training to subordinates on 21 CFR Part 211, 111 with data integrity (Part-11) compliance in the lab. - Maintain awareness about responsible care practices for Environment, Health, Safety, and Security. Qualification & Experience: - M.Sc. in Chemistry with 8-12 years of experience. Competencies: - Responsible for implementation & compliance with 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP. - Hands-on experience as a Reviewer of electronic data & hybrid system in a regulatory environment (US-FDA, WHO, etc.). - Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11). Note: No additional details about the company were provided in the job description.,