Y-Axis Jobs Logo
Send us feedback
telephone  +91 7670 800 001
Log in Sign up Try Premium
Officer, QMS at Amneal India
Ahmedabad, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

18 Oct, 26

Salary

0.0

Posted On

20 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Quality Assurance, Document Control, GMP Compliance, Change Control, Internal Auditing, Data Integrity, Batch Record Management, Regulatory Compliance, SOP Management, Quality Management Systems

Industry

Pharmaceutical Manufacturing

Description
Description:  * Manage, control, and maintain all Quality Assurance (QA) documents, records, and logs in compliance with GMP requirements. * Ensure timely issuance, retrieval, archival, and destruction of controlled documents according to approved procedures. * Maintain document revision history and ensure only current, approved versions are available for use. * Coordinate document review, approval, and distribution processes with QA, Production, QC, and other departments. * Monitor compliance with document control procedures and support internal audits and regulatory inspections. * Maintain electronic and physical document management systems, ensuring data integrity and confidentiality. * Track periodic review schedules for Standard Operating Procedures (SOPs), specifications, forms, and quality manuals. * Support change control activities by updating and distributing revised documents as per approved changes. * Prepare document control metrics, reports, and status updates for management review. * Ensure all documentation practices comply with applicable regulatory guidelines, including GMP, WHO, FDA, MHRA, and company quality standards. Additional Responsibilities: * Issue approved Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and associated controlled documents to Production as per the production plan and document control procedures. * Verify the completeness, correctness, and revision status of batch records before issuance, maintain issuance logs, and ensure reconciliation and retrieval of executed batch records after batch completion.
Responsibilities
Manage and maintain all Quality Assurance documents, records, and logs in compliance with GMP and regulatory requirements. Coordinate the issuance, review, and archival of controlled documents, including Batch Manufacturing and Packaging Records.