Senior Vendor Assurance Engineer

I am currently recruiting for a Senior Vendor Assurance Engineer to work in the Quality Systems Team of my global healthcare client based in Loughborough.

The ideal candidate will be responsible for leading and managing the vendor assurance for the site covering scheduling of audits, management of the audit days along with report generation and CAPA management for closure of the audit. The role will cover a diverse range of suppliers from API, excipient, packaging, distribution along with services supplied to the site. It is critical that candidates have audit experience/knowledge across various pharmaceutical suppliers and will ideally hold an ISO 9001 lead auditor qualification.

Key Capabilities and responsibilities:
*GMP, Regulatory, ISO standards and current best industry practice
*ISO 9001 Lead Auditor training qualification
*Excellent communicator at all levels of an organisation
*Able to work on own initiative and strong leadership skills with an excellent attention to detail
*Works well in a changing and challenging environment
*Requires understanding of API, excipient and packaging manufacturing and distribution
*Management and completion of audits to the audit schedule along with audit support from ISO 9001 lead auditors on the Loughborough site.
*Completion of Quality Operations report defining the years audit plan for sharing with regulatory and customer audits.
*Collaboration across site teams to ensure all preparation for audits is completed OTIF.
*Communication with supplies for Vendor Assurance activities and agreement of audit days
*Knowledge of Pharmaceutical suppliers
*Good communication and relationship skills
*GMP, Regulatory, ISO standards and current best industry practice
*Management of the audit days on site at the supplier to provide assurance to the company of manufacture to standards, regulatory requirements, supplier procedures and specifications.
*Completion of audit report with findings and supplier ratings.

More details available upon request.