Key Responsibilities
(Performance Indicators)
- Knowledge aboutIMS 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
