AM - Quality Control

The Assistant Manager - QC position at Bharuch SEZ requires a candidate with complete experience in API/Bulk/Intermediates industries as per global regulatory requirements. The individual will be responsible for the implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP, and other global QMS requirements at the SEZ site. Key responsibilities include regularizing QC activities as per cGMP requirements, ensuring regulatory and pharmacopeia compliance in the lab, reviewing hybrid and electronic data for IPQC and FG analysis, conducting analytical method validation, OOS, and OOT. The candidate should have knowledge about IMS system, analytical skills for QC instruments like GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point, and should be able to coordinate with QC staff, R&D, Commercial, and Production for quality and dispatch related activities. The Assistant Manager - QC will also be responsible for troubleshooting related to QC activities, training subordinates on 21 CFR Part 211, 111 with data integrity (Part-11) compliance in the lab, and maintaining awareness about responsible care (Environment, Health, Safety, and Security). The ideal candidate should have an M.Sc. in Chemistry with 8-12 years of experience. Competencies required include being responsible for implementation and compliances of various regulatory standards, hands-on experience as a reviewer of electronic data and hybrid systems in regulatory environments like US-FDA, WHO, and knowledge about 21 CFR Part 211, 111 with data integrity (Part-11). This role reports to the QC Head and will have 2-3 reportees. The Assistant Manager - QC will work closely with the Site Quality Head, CQA & RA Head, and Unit HR Head.,