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Associate, IPQA at Amneal India
Ahmedabad, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

29 Jul, 26

Salary

0.0

Posted On

30 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

IPQA, GMP Compliance, Line Clearance, In-process Checks, Documentation, Data Integrity, Process Validation, Cleaning Validation, Aseptic Processing, Deviation Management, Audit Readiness, 21 CFR Part 210, 21 CFR Part 211, BMR Review, BPR Review, Good Documentation Practices

Industry

Pharmaceutical Manufacturing

Description
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.  
Responsibilities
The role is responsible for ensuring continuous GMP compliance during manufacturing and packing operations through real-time quality oversight. Responsibilities include performing line clearances, in-process checks, and maintaining accurate documentation to ensure product safety and quality.