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.
* Valuable Documentation Practices (GDP), cGMP, and Data Integrity (ALCOA+).
* Regulatory Documentation, Audit Readiness, and Inspection Support.
* Analytical Thinking, Cross-Functional Coordination, and Technical
Documentation.

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