Executive - Vendor Management (Quality)

Glenmark Pharmaceuticals; Mumbai; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Glenmark Pharmaceuticals in Mumbai, India seeks an experienced QA professional to conduct vendor audits, qualification/routine audits, and risk assessments. You will review CAPA implementations, qualification documents, and changes for new or alternate vendors, following Global SOPs. Proficiency in SAP and TrackWise is required.

The role requires 10–15 years in pharma, with packaging experience preferred, and a strong foundation in ISO 9001, ISO 15378, and ISO 13485 standards.

Qualifications

• 10 to 15 years' experience in pharmaceutical industry.
• Experience in production packaging is preferred.

Responsibilities

• Conduct new vendor audits and qualification/routine audits for vendors.
• Review audit compliance reports and CAPA implementation at vendor end.
• Review and maintain vendor qualification documents.
• Evaluate change controls for new/alternate vendor introduction or for changes endorsed in view of vendor notifications.
• Perform annual vendor assessment in line with Global Vendor Management SOP.
• Perform SAP and TrackWise audit activities.
• Perform risk assessments of vendor/materials in case of quality events or regulatory observations.

Skills

ISO 9001 knowledge

ISO 15378 knowledge

ISO 13485 knowledge

Production experience

Packaging experience

Tools

SAP

TrackWise

Job description

• To conduct new vendor audits, requalification/routine audits, for-cause/risk-based audits for vendors manufacturing and supplying Primary and printed Packaging materials for Glenmark products.
• To review audit compliance reports and ensure the implementation of agreed CAPA at vendor end
• To review and maintain vendor qualification documents.
• To evaluate the Change controls for a new/alternate vendor introduction or for changes endorsed in view of vendor notifications.
• To perform annual vendor assessment in line with Global Vendor Management SOP.
• To perform SAP and Track wise audit activities
• To perform/ensure risk assessment of vendor/materials in case of critical Quality events or adverse regulatory observations. (WL/Import Alerts/GMP Non-compliance, CEP Suspension)

Experience:

• 10 to 15 years' experience in pharmaceutical industry
• Experience in production packaging is preferred

Knowledge & Skills:

• Well versed with reequipments of ISO 9001:2015, ISO 15378:2017, ISO 13485: 2016
• Experience in Production and Packaging
• Computer operating skills and pharmaceutical knowledge