Quality Compliance Officer

4 days ago

Copenhagen, Copenhagen, Denmark Norgine Full time

Norgine Copenhagen, Capital Region of Denmark, Denmark

2 days ago Be among the first 25 applicants

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 Compliance Manager.

This role is 13 months FTC / Maternity cover

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

Requirements

RESPONSIBILITIES

Ensure that Norgine's Nordics quality management systems are 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 perform 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.

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

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.

MAIN TASKS

  • Ensure that Norgine's Nordics quality management systems are maintained, under RP/Quality affiliate oversight, focusing on the management of authorised activities and accuracy and quality of records.
  • Keep appropriate records of any delegated duties and activities.
  • Act in capacity on behalf of the regional affiliate network cluster to perform delegated duties concerning regional WDA licences.
  • Ensure 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.
  • Ensure that initial and continuous training programs are maintained to assure competency in GDP for the regional cluster.
  • Ensure 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 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 times.
  • Participate and support external competent authority inspections alongside RP/GDP affiliate teams.
  • Development/management of quality documents and key performance indicators.
  • Approve any subcontracted activities which may impact on GDP.
  • Ensure that any additional requirements imposed on certain products within the regional cluster by national law are adhered to.
  • Archive 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.
  • Ensure that relevant customer complaints are dealt with effectively including recording of complaints and sharing with manufacturing sites.
  • Prepare documentation, update trackers, check batch documentation and communicate appropriately internally and externally.
Experience
  • Scientific Degree with a professional qualification and RP (Responsible Person) status would be advantageous.
  • Minimum of 3 years relevant pharmaceutical industry experience.
  • Experienced in supporting 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 recommendations/decisions and take appropriate action.
  • Language: Native Danish.
Benefits
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.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Legal
  • Industries
  • Non-profit Organizations and Primary and Secondary Education
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