Executive - Quality Control

As an Assistant Manager - Quality Control at Bharuch SEZ, you will be responsible for ensuring the implementation and compliance of global regulatory requirements such as 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP, and other global QMS requirements specific to API/Bulk/Intermediates industries. Key Responsibilities: - Regularize QC activities in accordance with cGMP requirements. - Ensure compliance with regulatory and Pharmacopeia requirements for lab operations. - Review hybrid and electronic data for IPQC & FG analysis. - Conduct analytical method validation, OOS & OOT investigations. - Demonstrate proficiency in IMS system (ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007, and cGMP). - 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 teams for quality and dispatch activities to ensure on-time dispatches. - Resolve troubleshooting issues 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 of responsible care principles related to Environment, Health, Safety, and Security. No. of Reportees: 2-3 Qualification & Experience: - M.Sc. in Chemistry with 8-12 years of experience Competencies: - Ensure implementation & compliance of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP standards. - Hands-on experience as a Reviewer of electronic data & hybrid systems in regulatory environments (US-FDA, WHO, etc.). - Knowledge of 21 CFR Part 211, 111 with data integrity (Part-11) compliance.,