We are proud to be working with this biopharma company and assist in developing their quality department for an exiting role heading up the auditing team.
MAIN DUTIES AND RESPONSIBILITIES
The Audit and Supplier Assurance Manager, will be responsible to:
• Provide 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 company
• Undertake internal audits of company activities supporting the manufacture and testing of company products.
• Ensure data integrity requirements are included into company 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 relevant training
• Undertake work in accordance with company Health and Safety policies and procedures and to work within the Quality System that are applicable to the site.
• Comply with company policies and procedures.