Senior Officer, QMS

Amneal Pharmaceuticals

Required skills

Website: amneal.com
Job details:
Description

JOB 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.

Education

QUALIFICATIONS

Experience:

Specialized Knowledge: Licenses: Click on Apply to know more.

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