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Job Description
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.
If you want to know about the requirements for this role, read on for all the relevant information.
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