SRG are excited to be working with a global name in the healthcare industry to help them find a Supplier Assurance Associate to join their QA team.

This is a great opportunity for someone with good QA experience from a cGMP environment and will provide training and development.

The Role:

• Leading supplier quality visits for primary, secondary and tertiary component manufacturers and contract goods.
• Dealing directly with supplier processes, validation of those processes and their quality standards
• Management of Supplier Corrective Action Report Procedure
• Manage Supplier score cards to ensure robust, risk-based processes for supplier scoping, approval and ongoing qualification to control and drive supplier continuous improvement.
• Manage third part contract good release to market, ensuring compliance and timelines are met
• Oversee the Vendor Approval System for API, excipient, packaging manufacturers, third party contract manufacturers and external service providers
• Provide trending data & reports upon request to senior management, functional managers, regulatory authorities & customers
• Lead on the investigation and Corrective & Preventative Actions relating to supplier Non Conformities including implementation and effectiveness checks
• Documentation Owner for Supplier documentation including creation, document management and authorisation of Artwork
• Act as an SME supporting inspections

Requirements:

• Degree in a relevant scientific discipline
• Experience working within QA in a cGMP environment
• Experience of supplier audits and/or vendor assurance would be beneficial
• Excellent organisational and time management skills
• Good knowledge of GMP and ISO regulations
• Awareness of regulatory requirements

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.