Quality Assurance (QA) Expert

Function

As Quality Assurance (QA) Expert, you will be responsible for :

• Maintaining and supporting the Quality Management System, and ensuring EMVO’s owned systems and services’ compliance
• Reporting to the Quality Assurance Manager
• QA SPOC for assigned systems/processes
• Supporting the QA review of Change Requests
• Following up on the Quality Events and CAPAs
• Providing EMVO departments with Quality Assurance training
• Representing EMVO Quality Assurance in European Medicines Verification System InterOperability Tests
• Participating in Risk Assessments
• Assisting in the organisation of external audits and the execution of internal audits
• Coordinating IT Security Audits

Profile

• Master’s degree preferably in IT, Engineering, Pharmaceutical Sciences or Life Sciences
• Minimum 2 years’ of experience in the Quality Assurance field
• Experienced in Computerised Systems Validation
• Experienced in the following Regulations/Best Practices:
  • Eudralex Volume 4 and Annexes
  • ISO 9000 series
  • GAMP5 – Computer System Validation
  • ITIL.
• Highly proficient in the use of the MS Office
• Excellent written and spoken English is absolutely vital to join this multicultural team where English is the working language
• Strong interpersonal and communication skills to maintain excellent working relations with international supply chain stakeholders
• A keen eye for detail
• Results-driven approach
• It is an asset if you have:
  • Experience with IT, including audits and inspections
  • Experience in a multicultural European environment
  • Experience in the Pharmaceutical Supply Chain

Offer

• As the Quality Assurance (QA) Expert at EMVO, you will join a stable, multicultural, highly motivated team of 3, working in an industry that is vital for today’s evolving society.
• EMVO will also offer you:

• • A challenging permanent position working with ground-breaking systems in major projects
  • Full-time job (40h/week)
  • 32 holidays
  • We offer an attractive remuneration package including meal vouchers, eco vouchers, group insurance, (pension, death and invalidity), health insurance, (hospitalisation and ambulatory), public transport subscription and Homeworking, up to 4 days a week