Posted:1 month ago|
Platform:
Work from Office
Full Time
Position Assistant Manager - Quality Control Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;;; Reports to QC Head; Summary of Job (Purpose/ objective of the job Department Organogram to be enclosed) candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Regularize the QC activities as per cGMP requirements. Regulatory and Pharmacopeia requirement for lab compliance. Review of hybrid and electronic data for IPQC and FG analysis.; Analytical method validation, OOS and OOT.; Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP. Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Resolve the trouble shooting related to QC activities.; Training to subordinate and employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab. Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees 2-3 numbers Qualification and Experience M.Sc. (Chemistry) with 8-12 yrs. y Competencies; (Technical, Functional and Behavioral) Responsible for implementation and compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP. Hand-on experience as Reviewer of electronic data and hybrid system in regulatory environment (US-FDA, WHO etc.) Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11)
Jubilant Ingrevia Limited
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