Job 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.

Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.