Assistant Officer- QC

Job Description

Business Unit / Function Department - Quality Control Location Bharuch; SEZ;;; Reports to Lab In charge-QC 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 ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site. Key Responsibilities (Performance Indicators) Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP, USFDA, FSSC - 22000, NABL . Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc. Regularize the QC activities as per cGMP requirements. RM, PKG, In-process and FG sampling and Analysis. Co-ordination with QC staff, R and D, Commercial and production for quality and dispatch related activities for on time dispatches. Day to day monitoring and execution online all IPQC and FG analysis activities. Resolve the trouble shooting related to QC activities. Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11) Awareness about responsible care (Environment, Health, Safety and Security) No. of Reportees Qualification and Experience M.Sc. (Chemistry) with 2 - 6 yrs. Key Competencies (Technical, Functional and Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument