GMP Partner

5 hours ago

Gentofte Kommune, Denmark Novo Nordisk AS Full time

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Does GMP run in your blood, and are you motivated by setting high standards for GMP and quality in our production facilities, and continuously improve our processes and the way we work? 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 as GMP Partner that we are looking for in PS Aseptic Manufacturing in Gentofte, apply and join us

The position
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 be a central reference person in the department in relation to quality and compliance, and a large part of your job will be related to daily sparring and coaching regarding production challenges, deviations, change requests, improvements and related topics.

As department GMP Partner, you will report to the department director and be a part of the management team.

You will:

  • Coach, and assist, your colleagues in GMP related tasks such as deviations and changes (delimitation, corrective & preventive actions, qualification etc.).
  • Maintain high-level GMP and quality overview and report on GMP and quality trends to management.
  • Take part in the management of the department with relation to GMP and quality, participating in management meetings, setting direction and drive actions & projects across the department.
  • Drive department level quality related activities, plans and documents, such as quality management review, overview of validation status etc.
  • Drive, coach and facilitate quality improvement initiatives such systematic problem solving, continuous improvement, standardisation, and simplification.
  • Drive 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 partner network with the area, and in cooperation 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 tasks 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.

Qualifications
Ideally:

  • MSc/BSc within pharmacy, chemical engineering, chemistry/biology or similar.
  • Around 3+ years’ experience from the pharmaceutical or medical device industry, or similar related areas.
  • Ability 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.
  • Able to think and act with a broad and holistic perspective, seeing “The Big Picture” without losing sight or interest in important details.
  • Familiar and confident with complex production processes and have experience from GMP regulated areas. Experience with production of sterile medicinal products will be a strong plus.
  • Novo Nordisk is an international company, so you are fluent verbally and in writing in English, with proficiency in Danish being a plus.

As an individual you are positive, cooperative, action and solution orientated, and you work systematically, logically and proactively.
Your position will have a large contact base, within- and outside the department, and being a part of the management group, you are expected to be able to work independently, shaping your job and impact and being motivated by the results you provide, so you should thrive with the flexibility and possibilities, but also the uncertainty, this provides.

About the department
PS Aseptic Manufacturing Gentofte is responsible for aseptic filling & freeze drying of biopharmaceutical medical products within the rare blood disorders and diabetes area using isolator technology. In addition to production for the market, we also qualify and produce Novo Nordisk’s new protein-based biopharmaceutical medicines for clinical trials.

The department, which employs approx. 140 colleagues, currently operates 1 isolator line producing freeze dried products for the market and is responsible Product and Process Implementation across the site, and is characterized by highly engaged, professional colleagues and an open, respectful and involving atmosphere.

The department is based at two locations close to each other in the Gentofte area.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop; we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact
If you want to know more about the position, please contact Director, Martin Steen Bothmann at +45 3079 0057

Deadline
26 January 2025

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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