Assistant Manager - Quality Control

Designation - Asst. Manager QC

Role & responsibilities

• Regularize the QC activities as per cGMP requirements.
• Regulatory & Pharmacopeia requirement for lab compliance.
• Review of hybrid & electronic data for IPQC & FG analysis.
• Analytical method validation, OOS & 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&D, Commercial and production for quality & dispatch related activities for on time dispatches.
• Resolve the trouble shooting related to QC activities.
• Training to subordinate & employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab.
• Awareness about responsible care (Environment, Health, Safety and Security)

Preferred candidate profile

Candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation & compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site.