Department GMP Partner

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Kalundborg

Do you have a passion for GMP, and are you motivated by setting high standards for GMP and ensuring that we continuously improve our processes and ways of working? Do you get energy from having a large contact base, being part of the management team, and the possibility to work with highly qualified colleagues within your field? Then you may be the new colleague we are looking for Biotech & Rare Disease Filling in Kalundborg.

The position
As Good Manufacturing Practice (GMP) Partner you will be responsible for supporting management and your colleagues in maintaining and developing a high GMP and quality standard within the department and our production. You will have the opportunity to be involved in coaching and assisting your colleagues in GMP related tasks such as deviations and changes (delimitation, corrective & preventive actions, qualification etc.) and maintaining high-level GMP and quality overview and report on GMP and quality trends to management.
Other responsibilities include:

  • Driving department level quality related activities, plans and documents, such as quality management review, overview of validation status, quality risk assessment and contamination control strategy etc.
  • Driving, coaching and facilitating quality improvement initiatives such systematic problem solving, continues improvement, standardisation, and simplification.
  • Driving preparation for and follow-up on authority inspections and internal audits.

In addition to your tasks in the department, you will be part of the GMP networks within the area, and in corporation with your peers in the other departments address tasks and challenges that reach across the areas, such as inspection preparation, implementation of new systems or procedures etc.

Your job will be characterized by a dynamic mix of coordination, follow-up and participation in management related activities and execution of your own task in a more focused manner, so you must be able to, and motivated by, a flexible workstyle and ability to prioritize your own tasks and time.

This position offers many development opportunities and can be a starting point for different career paths in Novo Nordisk. Also, over time you will potentially be a part of the management team.

Qualifications
To succeed in this role, you have:

  • An academic degree within pharmacy, chemical engineering, chemistry/biology or similar.
  • Preferably +3 years of experience from the pharmaceutical or medical device industry or similar related areas.
  • Experience with complex production processes and from GMP regulated areas.
  • Strong skills within cLean (ex. a 2star certification or similar - education within A3 SPS).
  • A broad and holistic perspective, seeing “The Big Picture” without losing sight or interest in important details.
  • Full professional proficiency in English.

As individual you are positive, corporative, action and solution orientated, and you work systematically, logically and proactive. You are able to interact and communicate at all levels of the organisation, from operator to management, and you take pride in solving your tasks and challenges as close to the process as possible, with close involvement of your key stakeholders. You take initiatives on your own, and to ensure commitment from your stakeholders, you have great focus on change management when introducing your ideas.

About the department
BRD Finished Products Kalundborg is part of our largest production complex in Novo Nordisk. Here we are app. 520 colleagues who take responsibility for transforming Active Pharmaceutical Ingredients into the finished product that patients can use all over the world. We rely on our stabile/well-run/best-in-class packaging department and our newly established high-tech and high-volume filling facility. Our complex processes require a high level of expertise, commitment, and engagement from our employees and include formulation, filling, freeze-drying, product inspection, assembly, and pack. We bring value to patients by delivering high-quality Good Manufacturing Process (GMP) compliant products in a timely and cost-efficient manner. We drive change by working actively with LEAN and always looking for improvements within our processes but also in the way we work together to make our products reach as many patients as possible.

Working at BRD, Novo Nordisk
Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2500 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career?

Contact
Do you have any questions regarding the position or want to know more? Feel free to contact Senior Manager Marianne Espenhain at +45 30 79 82 50.

Deadline
November 20th, 2022. We will review and conduct interviews on an ongoing basis.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Kalundborg.

Jobbet er oprettet på vores service den 27.10.2022, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Kalundborg

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