Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

Position Summary:

Reporting directly to the Manager, Quality, this position in charge of fulfilling lead administrative tasks for all audit management activities at FBS Bleiswijk, including client audits, the self-inspection program and supplier management audits (as required). This position is also responsible for acting as the primary audit host for client audits. Further to this, the Audit Associate will be required to provide assistance the Manager, Quality during regulatory inspections.

Key Responsibilities:

· Being the primary contact with the auditor(s) and internal business unit to agree upon a suitable date(s) and communicate to the site as appropriate.

· Arrangement of any required room booking, catering requirements and/or remote audit workspaces.

· Assuming lead responsibility for client audit requests for documentation (both prior to and during audits), providing these in a timely manner via the approved medium.

· To complete Inspection Readiness activities and pre-audit GEMBA walks prior to client audits to identify potential areas of deficiencies and communicate these to local Site Leadership

· Hosting client audits, preparing responses to audit reports (CAPA Plan) from the business post audit and entering information into the Trackwise system.

· To co-ordinate the internal audit program and routinely supervise adherence to the annual plan.

· Perform self-inspections according to the approved yearly audit program.

· To provide data and site metrics related to site audits to the Quality Assurance Manager, Quality and the Senior Manager, Quality as required.

· To provide support to the Global Supplier Quality team as required.

· Identify and raise concerns when timelines are not being met.

· Perform other compliance/Quality duties as required by the site QA Manager.

Minimum Requirements/Qualifications:

· Higher education qualification

· Knowledge of pharmaceutical GMP and/or an equivalent regulated industry

· Experience in Quality Management System administration

Crucial Skills/Experience: · Able to work as part of a team providing support to other members. · Ability to work without direct supervision/on own initiative within the remit of the role · High degree of accuracy and attention to detail · Excellent verbal and written communication skills to all levels of the business internally as well as to external clients/3rd party auditors · Strong organizational skills. · Good problem solving and decision making skills. · Proficient with basic IT and computer software packages. · Employment is subject to 10 year history screening for criminal records, qualifications, previous employment and credit history – Thermo Fisher Scientific have the right not to employ people failing to meet the standards required · Fluent in English