Senior Officer, QMS

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.

Qualifications

Education:

• B. Pharm B. Pharm - Required

• M. Pharm M. Pharm - Preferred

Experience:

• 1 year or more in 1 - 4 Years

Specialized Knowledge: Licenses: