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
- Strong understanding of API manufacturing processes and IPQA controls.
- Excellent documentation and compliance skills.
- Good communication and coordination abilities.
- Attention to detail and problem-solving mindset.
- Ability to work in shifts and handle shop-floor QA activities.
Qualifications
QUALIFICATIONS
- M.Sc. in Chemistry (mandatory).
- Sound knowledge of cGMP, ICH guidelines, and API regulatory requirements.
