Assistant Manager, IPQA

Amneal Pharmaceuticals • Full-time • Dahej, IN • 1w ago

Essential Functions:

JOB DESCRIPTION

Take regular plant rounds to monitor production activities and ensure cGMP compliance at the shop floor level.
Review and approve Batch Manufacturing Records (BMR), Batch Cleaning Records (BCR), and related analytical records prior to release of API.
Prepare and revise SOPs, BMRs, BCRs, BPRs, and other QA-related documents in line with regulatory and internal requirements.
Perform sampling of APIs, maintain related records, and ensure proper cleaning and maintenance of sampling tools.
Maintain records and storage of control samples of API as per defined procedures.
Provide line clearance at every product changeover stage, ensuring readiness of area and equipment.
Monitor dispatch process and review records related to finished goods dispatch to ensure compliance.
Coordinate and support investigations of deviations, incidents, and non-conformances with QA Head/Designee.
Participate in Product Quality Reviews (PQR) for all APIs, compiling relevant data and identifying improvement areas.
Monitor process and cleaning validation activities on the shop floor to ensure compliance with protocols.
Support data integrity, documentation practices, and readiness for internal/external audits.
Coordinate with production, QC, engineering, and warehouse teams for day-to-day IPQA requirements.

Additional Responsibilities:

Participate in risk assessments (HIRA), change controls, and CAPA implementation related to IPQA.
Support training of QA executives and production personnel in cGMP, documentation, and in-process control requirements.
Assist in handling of quality events such as market complaints, recalls, and audit observations.
Contribute to continuous improvement initiatives within QA and across departments.
Ensure readiness and compliance for regulatory inspections and internal quality audits.
Lead initiatives related to QMS enhancements and harmonization of documentation practices.
Maintain logs, registers, and master data related to IPQA activities.
Monitor and report compliance KPIs to QA management.
Act as QA representative in daily production meetings and batch release discussions.

Qualifications :-

Education: