Quality Compliance Officer GDP

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 GDP to join Norgine.

The core responsibility of the Quality Compliance officer GDP:

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

Quality oversight and overall responsibility on compliance of country Wholesale Dealers Licence with EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products for Human Use. Act as Responsible Person Norgine GmbH according to § 52a Absatz 2 Nr. 3 Arzneimittelgesetz (AMG).

Act as Responsible Person (RP) on the Norgine Wholesale Distribution licence, 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.

Act as local person responsible for Regulatory compliance and ensure the management and Quality Assurance of the distribution activities of the medical devices. This person also have accurate knowledge of the legislation and other regulations applicable to medical devices, according local legislation. Overall responsibility according to general obligations of manufacturers (Article 10 EU Medical Device Regulation 2017/745 of the EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 for Medical Devices) lies with legal manufacturer Norgine BV.

Ensure legal entity have Wholesale Dealers licences in place that are compliant with GDP expectations set in the EC Guidelines of 5 November 2013 on GDP of medicinal products for human use.

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.

Releasing of medicinal product and medical devices to the market from batches received in the warehouse from different supplier and prior to distribution

Overall responsibility of the process for National Administrative releases

Coordinate release activities with supporting GDP colleagues

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

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.
• Ensure that suppliers and customers involved in any outsourced activity which may impact on GDP are qualified and in approved status according to Norgine qualification program; monitor and review their performance to identify and implement any required improvements
• In case a recall for medicinal products is deemed necessary, support the Norgine GmbH “Stufenplanbeauftragte” to coordinate and promptly perform any necessary operation
• 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
• Perform the data generation and preparation 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
• Lead the revision /administration of local GDP SOPs, WI, Forms, templates and support updates of global documentation
• Ensuring that relevant customer complaints are dealt with effectively including recording of complaints and sharing with manufacturing sites
• Perform national administrative releases of product to market once received from the manufacturer and prior to distribution
• Prepare documentation, update trackers, check batch documentation and communicate appropriately internally and externally.

EXPERIENCE

• A scientific degree is essential and suitability for immediate registration as a Responsible Person is mandatory
• Sufficient experience to act as the responsible professional resource in field
• Minimum of 3 years relevant pharmaceutical industry experience.
• Experience auditing in GDP /ISO environments
• Experience with regulatory and ISO inspections
• Experienced in leading successful regulatory inspections.
• Good knowledge of regulatory requirements impacting the pharmaceutical and medical device industries, in particular the pharmaceutical distribution environment with good knowledge of GMP/GDP.
• Excellent influencing skills and ability to establish effective working relationships with personnel at Norgine or distribution partners.
• Excellent verbal and written communication skills ability to present effectively to groups
• Proven ability to use Quality Management Systems and KPI reporting to best advantage in support of compliance and continuous improvement.
• Proven ability to make science based, data driven recommendation/decisions and take appropriate action.

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

Sound good? Find out more about the career you’ll have with Norgine, then apply here.