Senior Officer / Executive - Vendor Qualification

Alivus Life Sciences; Ankleshwar; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Alivus Life Sciences in Ankleshwar, Gujarat, India, seeks a Vendor Qualification Specialist to ensure audit compliance for contract laboratories, contract manufacturers, and external service providers. You will review qualification documents, perform SAP transactions, and manage change controls related to vendor qualification.

The role requires 5-10 years in pharma QA, SAP knowledge, and audit management experience; exposure to external service providers is preferred.

Qualifications

• 5-10 years of experience in vendor qualification / Change Control / QA within pharma or life sciences.
• Working knowledge of SAP, change control processes and audit management.
• Exposure to contract manufacturer / CL qualification and external service provider audits preferred.

Responsibilities

• Ensure compliance of vendor Qualification system.
• Audit vendor/ contract laboratory/ contract manufacturer/external service providers and ensure audit compliance.
• Review vendor qualification documents per requirements.
• Perform SAP transactions for vendor qualification.
• Execute Q-info activities in SAP system.
• Initiate change control and deviation related to vendor qualification, contract manufacturing and external services.
• Handle raw material code related activities.
• Prepare vendors audit planner and vendor assessment for yearly review.
• Ensure compliance status of contract manufacturing sites and agreements.
• Archive vendor qualification documents in compactor.
• Maintain SAP data transcription transactions.
• Maintain external quality control laboratories and services lists.
• Qualification and audit of external service providers and contract laboratories.
• Maintain list of External service providers.

Skills

Vendor qualification

Change control

Quality Assurance

SAP

Tools

SAP

Audit management

Job description

Role & responsibilities

• 1. To ensure compliance of vendor Qualification system.
• 2. To perform vendor/ contract laboratory/ contract manufacturer/external service providers audit & ensure audit compliance.
• 3. To review vendor qualification documents as per requirements.
• 4. To perform required transaction in SAP system for vendor qualification.
• 5. To perform Q-info related activities in SAP system.
• 6. Initiation of change control and deviation related to vendor qualification, contract manufacturing and external services.
• 7. To perform raw material code related activities.
• 8. Preparation of vendors audit planner and vendor assessment of KSM and intermediate for each year.
• 9. To ensure the compliance status of contract manufacturing sites and agreements.
• 10. Handling and archival of vendor qualification documents in compactor.
• 11. To perform the required transactions in SAP for data transcription.
• 12. To maintained list and audit planner of external quality control laboratories and list of external quality control services.
• 13. To perform the qualification and audit of external service provider and contract laboratories.
• 14. To maintained the list of External service provider.
• 15. To perform the activities as per requirement using applicable software(s).

Preferred candidate profile

• 1. 5-10 years of experience in vendor qualification / Change Control / QA within pharma or life sciences.
• 2. Working knowledge of SAP, change control processes and audit management.
• 3. Prior exposure to contract manufacturer / CL qualification and external service provider audits preferred