Amneal Pharmaceuticals
Website:
amneal.com
Job details:
Description
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
QUALIFICATIONS
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses:
About Us
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.
About The Team
The
Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
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