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 Valuable 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.

Education:

- B. Pharm B. Pharm - Required

- M. Pharm M. Pharm - Preferred

Experience:

- 1 year or more in 1 - 4 Years

Specialized Knowledge: Licenses:

📌 Senior Officer, QMS (India)
🏢 Amneal Pharmaceuticals
📍 India