Quality Compliance Officer

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 Compliance Officer to join Norgine.

The person holding this position will report to the Quality Compliance Manager.

The Quality Compliance Officer is responsible for providing support to the Regional cluster France & BeNeLux with regards to Good Distribution Practice (GDP) and product compliance related activities.

**RESPONSIBILITIES**

Ensure that Norgine’s regional clusters quality management systems is maintained, under RP/Quality affiliate oversight, focusing on the management of authorised activities and accuracy and quality of records.

Act in a capacity on behalf of Norgine’s regional cluster to performed delegated duties concerning regional Wholesale Distribution licences, in accordance with EudraLex Vol 4 and in particular EUROPEAN COMMISSION Guidelines of 5 November 2013 on GDP of medicinal products for human use and in accordance with the French regulation article R.5124-2 du Code of Public health.

Perform the process of batch release for the national administrative releases of product to market once received from the manufacturer and prior to distribution.

Ensure the batches follow up and declaration of shortage or risk of shortage for Major Therapeutic interest to relevant stakeholders

Generate regional metrics that deliver a clear understanding of the levels of compliance through the distribution network, to responsible management. Identifying noncompliance and associated risks and contribute to risk reduction strategies with clearly communicated action plans.

Act in a capacity on behalf of Norgine NV as Responsible Person (RP) for GDP on the Norgine NV (NNV) Wholesale Distribution license, in accordance with EudraLex Vol 4 and in particular EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use and the Belgian Royal Decree of 14-12/2006 art.94 - 10.

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

**Requirements**:
MAIN TASKS
- Ensure that Norgine regional cluster quality management systems is maintained, under RP/Quality affiliate oversight, focusing on the management of authorised activities and accuracy and quality of records.
- Keeping appropriate records of any delegated duties and activities
- Act in capacity on behalf of regional affiliate network cluster to performed delegated duties concerning regional WDA licences.
- Ensuring that suppliers and customers are approved
- In case a recall for medicinal products is deemed necessary, promptly perform any necessary operation for the regional cluster
- Ensuring that initial and continuous training programs are maintained to assure competency in GDP for the regional cluster
- Ensuring that self-inspections are performed at appropriate relevant intervals following a pre-arranged programme, participate in GDP self-inspections for regional clusters and ensure necessary corrective measures are put in place
- Support the data generation and perform for the quality management reviews
- Participate in Regional Inspection readiness activities to ensure adherence to the applicable internal and external standards of compliance at all time.
- Participate and support external competent authority inspections alongside RP/GDP affiliate teams
- Development/management of quality documents and key performance indicators
- Approving any subcontracted activities which may impact on GDP
- Ensuring that any additional requirements imposed on certain products within regional cluster by national law are adhered to
- Archiving GDP Information following records retention procedures
- Support RP/GDP Affiliate quality teams to ensure RP responsibilities are upheld
- Assist in revision /administration of local SOPs, WI, Forms and templates regarding GDP activities.
- Ensuring that relevant customer complaints are dealt with effectively including recording of complaints and sharing with manufacturing sites
- Deviation, CAPA and Change Control Management.
- Management of drug shortages.
- Support the process of batch documentation for the national administrative releases of product to market once received from the manufacturer and prior to distribution
- Prepare d