Job
Description
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. GC-HS, UPLC, 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 & Analysis. Co-ordination with QC staff, R&D, Commercial and production for quality & 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 instruments & activities. Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11), 217 Awareness about responsible care (Environment, Health, Safety and Security) Documentation work SOP Preparation, MOA Preparation, Investigation. No. of Reportees Qualification & Experience M.Sc.(Chemistry) with 2 - 6 yrs. Key Competencies (Technical, Functional & Behavioral) Handling, Calibration and Hand-on experience of all QC instruments. Compliance of 21 CFR Part-11. Troubleshooting related to QC analytical instrument
