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Senior 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

Stability Summary Reports, Document Control, cGMP, Good Documentation Practices, Data Integrity, ALCOA+, eDMS, Quality Management Systems, Regulatory Compliance, Audit Readiness, Technical Documentation, Cross-Functional Coordination

Industry

Pharmaceutical Manufacturing

Description
Description: * Prepare, review, and maintain Stability Summary Reports (SSRs) in accordance with approved stability protocols and regulatory requirements. * Compile and evaluate stability data received from QC and Stability teams to ensure accuracy and completeness of SSRs. * Manage document code creation, revision, issuance, and retirement as per the QA document control procedure. * Administer QA Documentation Cell activities, including issuance, control, retrieval, and archival of GMP documents. * Review SOPs, specifications, protocols, reports, and other quality documents for compliance with cGMP and Good Documentation Practices (GDP). * Ensure effective document lifecycle management through the Document Management System (DMS/eDMS). * Coordinate with QC, Production, Regulatory Affairs, R&D, and Stability teams for timely preparation and approval of SSRs and controlled documents. * Support internal audits, customer audits, and regulatory inspections by providing controlled documents and stability-related records. * Ensure compliance with data integrity (ALCOA+), document retention requirements, and applicable regulatory guidelines. * Drive continuous improvement and digitalization initiatives to enhance documentation and stability reporting processes.   Additional Responsibilities: * Stability Summary Report (SSR) Preparation and Stability Data Review. * Document Management System (DMS/eDMS) and Document Control. * Good Documentation Practices (GDP), cGMP, and Data Integrity (ALCOA+). * Regulatory Documentation, Audit Readiness, and Inspection Support. * Analytical Thinking, Cross-Functional Coordination, and Technical Documentation.
Responsibilities
Responsible for preparing and reviewing Stability Summary Reports and managing the lifecycle of GMP documents. This includes administering the QA Documentation Cell and ensuring compliance with cGMP and data integrity standards.