Function
As our Quality Assurance Expert, you will report to the Quality Assurance Manager and be playing a vital role in :
- Maintaining and supporting the Quality Management System, and ensuring EMVO’s owned systems and services’ compliance
- You will be the Quality Assurance SPOC for assigned systems/processes
- You are responsible for supporting the Quality Assurance 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
- You take ownership for coordinating IT Security Audits
Profile
- Master’s degree preferably in IT or Engineering
- Minimum 2 years’ of experience in the Quality Assurance field and/or IT field
- 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
- 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 in Computerised Systems Validation
- Experience in audits and inspections
- Experience in a multicultural European environment
- Experience in the Pharmaceutical Supply Chain
Offer
- As our Quality Assurance Expert 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
Languages
Excellent written and spoken English is absolutely vital to join this multicultural team where English is the working language
