Amneal Pharmaceuticals
Website:
amneal.com
Job details:
Description
JOB DESCRIPTION
The role is responsible for ensuring continuous compliance with global GMP (Good Manufacturing Practices) requirements during manufacturing, packing, and dispensing operations. The role focuses on real-time quality oversight, line clearance, and in-process checks to ensure products are manufactured in accordance with approved procedures and regulatory standards. The role performs routine shopfloor monitoring, verifies cleaning, sterilization, and aseptic activities, and ensures accurate documentation and data integrity. The role supports process validation, cleaning validation, and aseptic process simulations, and contributes to risk mitigation, deviation management, and audit readiness, ensuring consistent delivery of safe, high-quality pharmaceutical products.
Essential Functions
- Perform IPQA (In-Process Quality Assurance) checks during manufacturing and packing operations
- Execute and document Line Clearance and Readiness for manufacturing, packing, and dispensing
- Conduct In-Process Checks & Sampling (In-process, Stability & ANSI)
- 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 accuracy and completeness
- Ensure Good Documentation Practices (GDP – Good Documentation Practices) compliance.
Education
QUALIFICATIONS
- B. Sc- Required
- B. Pharm - Preferred
Experience
- 1 year or more in 1 - 4 Years
Specialized Knowledge: Licenses:
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