Officer, Quality Assurance

Actively Reviewing the Applications

Amneal Pharmaceuticals

India Full-Time On-site

Posted 3 weeks ago • Apply by April 28, 2026

Job Description

Job Description

JOB DESCRIPTION

The Officer – IPQA is responsible for performing in-process quality assurance activities during API manufacturing operations in compliance with cGMP requirements. The officer ensures proper line clearance, equipment cleaning verification, and adherence to GMP and safety practices on the shop floor

Key Responsibilities

Perform in-process quality assurance (IPQA) activities for API manufacturing as per cGMP requirements.
Monitor critical process parameters, sampling activities, and in-process controls on the shop floor.
Review and verification of batch manufacturing records (BMRs), logbooks, and production documents.
Ensure compliance with SOPs, GMP, safety, and data integrity practices.
Handling and documentation of deviations, OOS/OOT, change controls, and CAPA in coordination with cross-functional teams.
Support internal, external, customer, and regulatory audits; ensure timely closure of audit observations.
Verification of equipment cleaning, line clearance, and process adherence.
Coordination with Production, QC, Engineering, and EHS teams for quality-related issues.

Skills Required