Quality Assurance
il y a 5 jours
**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
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