Amneal Pharmaceuticals
Website:
amneal.com
Job details:
Description
JOB DESCRIPTION
The role is responsible for supporting cGMP (current Good Manufacturing Practices) compliant tablet compression operations within the Oral Solid Dosage (OSD) manufacturing area. The role ensures safe, consistent, and efficient compression activities by operating and monitoring tablet compression machines, performing in-process checks, and maintaining accurate batch documentation. The role supports line clearance, machine setup, changeovers, and basic troubleshooting under supervision while strictly following approved Standard Operating Procedures (SOPs). The role also involves maintaining online manufacturing records, adhering to Quality, Safety, and Environmental requirements, and coordinating with Production, Quality Control (QC), and Quality Assurance (QA) teams to ensure uninterrupted manufacturing operations and regulatory compliance.
Essential Functions
- Support tablet compression (Tablet Pressing) activities as per approved Batch Manufacturing Record (BMR) and Batch Production Record (BPR)
- Operate compression machines under supervision and monitor critical process parameters
- Perform In-Process Checks (IPQC – In-Process Quality Control) for tablet weight, hardness, thickness, and appearance
- Ensure cGMP (current Good Manufacturing Practices) compliance during batch execution
- Maintain Good Documentation Practices (GDP) through accurate online record updates
- Assist in line clearance and readiness activities before and after batch operations
- Support punches & dies handling and maintenance during setup and changeovers
- Follow change room gowning techniques and cleanroom discipline
- Report deviations, abnormalities, or equipment issues to seniors promptly
- Coordinate with QA, QC, and Engineering teams during routine operations and audits
- Adhere to Environmental, Health & Safety (EHS – Environment, Health and Safety) practices at all times
Additional Responsibilities
- The role involves ensuring CGMP compliance and supervision activity in manufacturing.
- Responsibilities include basic knowledge about compression machine and performing in-process checks during batch execution.
- The position requires maintaining online documents.
- IPQA instruments (e.g. Balance, Hardness, DT machine, Friability) calibration.
Education
QUALIFICATIONS
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 1 year or more in 1 - 4 Years
Specialized Knowledge: Licenses:
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