Job Description
Executive- Corporate Quality Assurance
Key Responsibilities:
1. Vendor & Supplier Qualification & Documentation:
• Review and maintain documentation such as:
• Vendor Assessment Questionnaires (for Raw Material & Packing Material)
• Supplier Assessment Questionnaires (for Raw Material & Packing Material)
• Inspection Reports
• Vendor/Supplier Approval & Disqualification Forms
• Coordinate with site and head office personnel to gather required vendor/supplier documents.
• Organize and perform desk audits for APIs, key starting materials, and packing materials.
2. Inspections & Audits:
• Conduct vendor inspections for:
• Starting materials
• Packing materials
• Contract testing laboratories
• Contract manufacturing sites
• Other service providers
• Perform supplier inspections for raw and packing materials.
• Prepare and maintain audit reports and follow up on CAPA implementation.
3. Material & Quality Communication:
• Notify Commercial and applicable site departments of any material rejections.
• Liaise with internal stakeholders regarding sourcing, documentation, and inspection outcomes.
4. Documentation & System Management:
• Maintain proper control and lifecycle management of quality documents including issuance, retrieval, archival, and destruction.
• Manage records of vendor complaints across all sites and ensure CAPA monitoring and closure.
• Prepare and maintain internal Corporate QA documents.
• Use Document Control System (DCS) software for document issuance, retrieval, and obsolescence.
• Manage Master Product Number (MPN) creation, extension to other locations, and resolve source-related issues in SAP.
Qualifications and Experience:
• Bachelor’s/Master’s degree in Pharmacy, Chemistry, or related science discipline.
• 8–10 years of experience in Quality Assurance within the pharmaceutical industry.
• Experience in vendor/supplier qualification, audits, and regulatory compliance.
Key Responsibilities:
1. Vendor & Supplier Qualification & Documentation:
• Review and maintain documentation such as:
• Vendor Assessment Questionnaires (for Raw Material & Packing Material)
• Supplier Assessment Questionnaires (for Raw Material & Packing Material)
• Inspection Reports
• Vendor/Supplier Approval & Disqualification Forms
• Coordinate with site and head office personnel to gather required vendor/supplier documents.
• Organize and perform desk audits for APIs, key starting materials, and packing materials.
2. Inspections & Audits:
• Conduct vendor inspections for:
• Starting materials
• Packing materials
• Contract testing laboratories
• Contract manufacturing sites
• Other service providers
• Perform supplier inspections for raw and packing materials.
• Prepare and maintain audit reports and follow up on CAPA implementation.
3. Material & Quality Communication:
• Notify Commercial and applicable site departments of any material rejections.
• Liaise with internal stakeholders regarding sourcing, documentation, and inspection outcomes.
4. Documentation & System Management:
• Maintain proper control and lifecycle management of quality documents including issuance, retrieval, archival, and destruction.
• Manage records of vendor complaints across all sites and ensure CAPA monitoring and closure.
• Prepare and maintain internal Corporate QA documents.
• Use Document Control System (DCS) software for document issuance, retrieval, and obsolescence.
• Manage Master Product Number (MPN) creation, extension to other locations, and resolve source-related issues in SAP.
Qualifications and Experience:
• Bachelor’s/Master’s degree in Pharmacy, Chemistry, or related science discipline.
• 8–10 years of experience in Quality Assurance within the pharmaceutical industry.
• Experience in vendor/supplier qualification, audits, and regulatory compliance.
💡 Quick Summary
Seeking a career-building opportunity? The Corporate Quality Assurance position is now open for candidates interested in the IT Engineer & Developer Jobs sector. This role in Mumbai offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in IT Engineer & Developer Jobs is a plus.