Senior Officer, IPQA

Amneal Pharmaceuticals · Dahej SIR

Description:

The role is responsible for ensuring real-time compliance with global GMP (Good Manufacturing Practices) across manufacturing, packing, and dispensing operations. The role provides on-floor quality oversight, ensuring that all activities are executed as per approved procedures, regulatory expectations, and internal quality standards. The role performs line clearance, in-process checks, environmental monitoring, and documentation review, ensuring data integrity, product quality, and patient safety. The role actively supports cleaning validation, process validation, aseptic process simulations, and deviation management, while maintaining strong coordination with production, quality control, and engineering teams to ensure right-first-time manufacturing and inspection readiness.

Essential Functions:

Perform IPQA (In-Process Quality Assurance) activities during manufacturing and packing operations

To conduct Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Batch Packaging Record (BPR) and stability study protocol

To Issuance of Bottle label, Ouster and Medication guide for commercial batch

Oversee the Calibration of IPQA instruments

Execute and document Line Clearance and Readiness for manufacturing, packing, and dispensing areas

Conduct In-Process Checks and coordinate with IPQC (In-Process Quality Control)

Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Good Manufacturing Practice for Drugs)

Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for completeness and accuracy

Monitor Environmental Monitoring and routine manufacturing area compliance

Ensure assurance of cleaning, sterilization, and aseptic manipulations

Perform Sampling of Cleaning Validation and compile records

Support Process Validation Reports (PVR – Process Validation Report) activities

Participate in Aseptic Process Simulation (Media Fill) monitoring

Support Change Control & Deviation Management and CAPA (Corrective and Preventive Action) implementation

Conduct Routine GMP Inspections and review quality records of other departments

Additional Responsibilities:

Real-time Monitoring and Compliance Reporting.

Participation in Investigations.

Provide on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices.

Maintain IPQA-related documents and records in a state of audit readiness.

To have good written and verbal communication skills in English language.

The role is responsible for ensuring real-time compliance with GMP across manufacturing, packing, dispatch, operations. Responsible for equipment cleaning sampling. Responsible for finished product (API) sampling. Responsible for online batch record review and plant round in the shift operation. Responsible for batch record review. Knowledge of GMP, Data interity, audit, API manufacturing.

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