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Officer, Quality Assurance at Amneal India
, Andhra Pradesh, India -
Full Time

Start Date

Immediate

Expiry Date

28 Apr, 26

Salary

0.0

Posted On

28 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

API Manufacturing Processes, IPQA Controls, Documentation Skills, Compliance Skills, Communication Abilities, Coordination Abilities, Attention to Detail, Problem-Solving Mindset, Shift Work, Shop-Floor QA Activities

Industry

Pharmaceutical Manufacturing

Description
Job Description: The Officer – IPQA is responsible for performing in-process quality assurance activities during API manufacturing operations in compliance with cGMP requirements. The officer ensures proper line clearance, equipment cleaning verification, and adherence to GMP and safety practices on the shop floor Key Responsibilities: Perform in-process quality assurance (IPQA) activities for API manufacturing as per cGMP requirements. Monitor critical process parameters, sampling activities, and in-process controls on the shop floor. Review and verification of batch manufacturing records (BMRs), logbooks, and production documents. Ensure compliance with SOPs, GMP, safety, and data integrity practices. Handling and documentation of deviations, OOS/OOT, change controls, and CAPA in coordination with cross-functional teams. Support internal, external, customer, and regulatory audits; ensure timely closure of audit observations. Verification of equipment cleaning, line clearance, and process adherence. Coordination with Production, QC, Engineering, and EHS teams for quality-related issues. Skills Required: Strong understanding of API manufacturing processes and IPQA controls. Excellent documentation and compliance skills. Good communication and coordination abilities. Attention to detail and problem-solving mindset. Ability to work in shifts and handle shop-floor QA activities.
Responsibilities
The Officer is responsible for performing in-process quality assurance activities during API manufacturing operations. This includes monitoring critical process parameters and ensuring compliance with GMP and safety practices.