Quality Assurance
il y a 4 jours
**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
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