Executive - Corporate Quality · Mumbai

Aristo Pharmaceuticals is one of India's leading pharmaceutical manufacturing companies, committed to maintaining international standards in drug manufacturing and healthcare solutions.

Key Responsibilities

• Assist in maintaining and monitoring the corporate Quality Management System (QMS) across manufacturing locations.
• Review, update, and manage standard operating procedures (SOPs), protocols, and quality manuals.
• Support the logging, evaluation, and tracking of deviations, incident reports, and change controls.
• Assist in formulating and tracking Corrective and Preventive Action (CAPA) plans to ensure timely closure.
• Review batch manufacturing records (BMR) and batch packaging records (BPR) for compliance with cGMP norms.
• Participate in internal quality audits and support documentation readiness for regulatory inspections.
• Manage corporate document archival, version control, and document issuance processes.
• Coordinate with manufacturing plant QA teams to compile periodic quality review data and trend reports.
• Assist in the preparation of Annual Product Quality Reviews (APQR) and risk assessment documents.
• Review vendor qualification files and analytical test reports against established corporate specifications.
• Ensure regulatory compliance alignment with Indian FDA and global pharmacopeial standards.
• Support cross-functional quality improvement initiatives under the guidance of QA leadership.