ReQuire Consultancy are pleased to be partnering with a leading organisation based at Porton Down Science Park, who are looking to appoint an Audit & Supplier Assurance Manager to join their Quality Assurance & Compliance department.
Reporting to the QMS Manager, you will be responsible for the management of internal and supplier management teams and associated systems.
Main responsibilities include:
Providing leadership and management the audit team.
Manage the audit and supplier approval management system, including scheduling, site audits, questionnaires, BSE/TSE assessments.
Maintain procedures and processes for auditing and supplier assurance activities.
Undertake site audits of critical suppliers and advice on their suitability for the business.
Undertake internal audits of company activities supporting the manufacture and testing of products.
Ensure data integrity requirements are included into site internal audits.
Liaise with internal customers, production staff, and quality staff to promote compliance with GMP and with internal customer requirements.
Manage and maintain Quality Technical Agreements with critical suppliers and sub-contractors.
Negotiate corrective and preventative actions necessary to achieve compliance.
Participate in hosting third part and regulatory audits/visits.
Provide technical and compliance guidance to project teams.
Keep up to date with regulatory requirements and technical advances and interpret their relevance/impact upon the team.
In line with responsibilities to perform other tasks assigned or objectives set by Line Management.
Assist with the QA overview of manufacturing and testing areas.
Provide KPI reports measuring the performance of the team.
Undertake work in accordance with Health and Safety policies and procedures and to work within the Quality System that are applicable to the site.
Person Specification:
Educated to degree level or HND in a relevant subject or equivalent level of experience of working at a similar level in specialist area
Experience in operating quality systems in a GMP environment
Proven experience in auditing to GMP and with Lead Auditor Qualifications.
Competent preparing and providing accurate and timely documentation.
Working knowledge of GMP, GCP, GLP, GDP and/or ISO
Comfortable working with multiple tasks and prioritising workload
Ability to communicate with a wide range of people
Strong documentation skills
Ability to deliver challenging messages in a constructive manner
For more information, please contact Carrie today or click apply!