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

Qualifications

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 Ahmedabad (India)
🏢 Amneal
📍 India