Hikal Limited Career Opportunity Assistant General Manager – Quality Assurance (API)

Hikal Limited, a global partner in the life sciences value chain providing world-class active ingredients and intermediates, is hiring a highly experienced professional for the position of Assistant General Manager – Quality Assurance.

This leadership role is based at the company’s API manufacturing facility in Jigani, Bangalore, and requires significant experience in regulated API environments.

Position Details and Requirements

Post: Assistant General Manager (AGM) – QA
Department: Quality Assurance
Job Location: Hikal Limited, KIADB Industrial Area, Jigani, Anekal Taluk, Bangalore-560105, India
Qualification: M.Sc. Chemistry
Experience: Minimum 18 to 20 years of experience in the QC Department (experience must be strictly from the API Industry only).

Key Responsibilities

The AGM – QA will be responsible for leading critical quality and compliance activities, including:

Investigations: Leading the investigation team and actively managing Out-of-Specification (OOS), OOT (Out-of-Trend), Deviations, OOC (Out-of-Compliance), and customer complaints.
Quality Systems: Managing Risk Assessment, CAPA (Corrective and Preventive Action), and Remediation activities.
Documentation & Compliance: Preparation of APQR (Annual Product Quality Review). Expertise in electronic systems like Trackwise, EDMS, and LIMS.
Vendor Management: Handling Vendor Qualification processes.
Regulatory Audits: Extensive experience in successfully managing and facing regulatory audits from agencies such as USFDA, ANVISA, PMDA, and EDQM.