Senior Officer, IPQA

Amneal Pharmaceuticals LLC; Hyderabad; On-site; INR 600,000 - 950,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Hyderabad, India, seeks an IPQA professional responsible for real-time GMP compliance across manufacturing, packing and dispensing. You will perform on-floor quality oversight, line clearance, in-process checks and maintain data integrity to ensure patient safety.

The role involves coordinating with production, quality control and engineering teams to enable right-first-time manufacturing and inspection readiness, including cleaning and process validations.

Qualifications

• GMP/IPQA experience or familiarity with CFR Part 210/211.

Responsibilities

• Perform IPQA activities during manufacturing and packing operations.
• Conduct sampling of reserve, stability and in-process checks per BPR and stability protocol.
• Issue bottle labels, outer labels and medication guides for commercial batch.
• Oversee calibration of IPQA instruments.
• Execute and document line clearance and readiness for manufacturing, packing and dispensing areas.
• Coordinate with IPQC for in-process checks and quality control.
• Ensure compliance with 21 CFR Part 210 & 211 for drug quality.
• Review BMR and BPR for completeness and accuracy.
• Monitor environmental monitoring and routine area compliance.
• Ensure cleaning, sterilization and aseptic manipulations are validated.
• Perform sampling of cleaning validation and compile records.

Job description

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