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)
