​QA Auditor

Location Leuven
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Competitive Salary + Generous benefits package
Job ref: 21363
Published: 9 days ago
Expiry date: 01 May 2021

​​Location: Leuven and flexible working

Our client is a clinical contract research organization (CRO) working from Phase I-IV delivering full-service across pharma, biotech and medical device sectors. They seek a QA Auditor to join their team in a variety of European locations, providing audit partnering to their international clients- post COVID this role will involve up to 50% travel.

Role Responsibilities:

  • Plan and execute internal system audits and external investigative site/vendor audits

  • Create, maintain, and revise departmental SOPs, forms, and templates

  • Coordinate, conduct, and track company-wide Regulatory Training (ICH/GCP, GLP, Medical Device)

  • Develop training materials and applicable tests and guides

  • Coordinate, conduct, track, and resolve CAPA investigations

  • Work with outside clients/sponsors and as a trusted partner with internal operations to promote a culture of continuous improvement

Essential Skills and Qualifications:

  • Bachelor’s degree in life sciences or nursing

  • Minimum 1 year experience in a QA department in pharma, biotech or medical devices

  • Experience of GCP site audits

  • Excellent written and verbal communication skills

  • Exceptional teamwork skills but also ability to work independently

This role is based in Munich, Leuven or Warsaw with extensive travel but will support flexible working on a part-remote basis, with 8 days a month from home going forward.

The benefits package includes medical insurance, dental and pension.

Please apply today to be considered or contact Katie Dunbar on +44 (0)1293 584300 or katie.dunbar@rbwconsulting.com for more information.

Salary: Competitive + Generous benefits package