Assistant Manager

3 days ago

Bharuch, India Jubilant Pharmova Full time

Job Description 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)

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