Assistant Manager - Quality Control

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)

Skills Required
Ims, Qc, Sop, Rm