Quality Officer En

4 weken geleden

Amsterdam, Nederland Norgine Voltijd

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Quality Officer to join Norgine in.

The person holding this position will report to Senior Quality Officer and be a member of the Quality team.

The External Network Quality Officer supports the External Network (EN) Quality Management System.

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

**Requirements**:

- Supports the External Network (EN) Quality Management System
- Support compliance of the quality system to cGMP
- Ensure and monitor quality records (Deviations, CAPA, complaints, PQR, Quality agreements etc.) are completed on time and maintained are in date
- Prepare monthly KPIs of EN for EN Quality Meeting and Quality Operations meeting.
- Present the monthly EN Quality Meeting.
- Prepare the EN Metrics Follow-up meeting.
- Controlled documentation coordinator role: ensure controlled documentation lifecycle and monitor documents revision
- CMO monitoring planning: Annual planning set-up and follow up completion (QAg, PQR, VMP, audit).
- Customer and Supplier complaint coordination back-up

**Key Committee Memberships**:

- External Network Quality Meeting

**RELATIONSHIPS**:

- Interact on a daily basis with Products Portfolio Quality Managers
- Interact with Supply Coordinators
- Interact with Global Quality Operations and Global Quality Assurance teams

**SKILLS & KNOWLEDGE**
- A scientific degree is required with 2 years relevant experience in a Quality environment in the pharmaceutical industry or a similar highly regulated environment, such as Medical Devices.
- Knowledge of GMP (Good Manufacturing Practice) and / or GDP (Good Distribution Practice).
- Strong communication and organisational skills are essential.
- Fluent in English (written and spoken), other language(s) a plus.
- Attention to details.
- Capacity to work autonomously on strict deadlines.
- Analytical skills : able to interpret and rationalise data output.
- Ability to perform audits, internally and externally is a plus.
- Ability to travel locally and internationally as required (occasional).

**Benefits**

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

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