Validation Coordinator for Matrix Operations

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Kalundborg

Are you looking for a position which offers a large amount of collaboration and ample opportunity to develop and shape your career? Are you highly motivated by complex challenges and a broad area of responsibilities within Project Execution Model (PEM) validation and have a keen eye on Quality and Compliance?

Then we have an exciting position for you in IM1 Projects, Kalundborg!

The position
As a Validation Coordinator you will have a central position in the team and in IM1 projects. You will be a key player and have a daily interaction with Production, Quality Assurance office and other parts of the organizations.

Your tasks will be diverse and ranging from:

  • Ensure that all cross-project disciplines are within the cGMP compliance guidelines
  • Be responsible for the QMS and IT platforms in IM1 projects
  • Take lead in standardizing the quality workflow ensuring simple and robust transition & handover between project office and production
  • Build Subject Matter Expert (SME) understanding of the Novo Nordisk Science and Risk-Based Validation Procedures
  • Be part of technical and validation core groups and make SME level knowledge available to project groups
  • Maintaining an up-to-date guidelines and SOP´s
  • Translate procedural requirements within validation area into practical workflows guiding the project execution
  • Build strong cross-functional relations with Novo Nordisk project organization and the supplier landscape (engineering, equipment vendors, contractors, etc.)
  • Be part of project planning and coordinating through cLEAN performance culture and board meetings

This position gives you a great opportunity to influence and develop your own carrier path, as you will hold one of the important roles in the IM1 projects department.

Qualifications
You have a technical background within Pharmacy, Engineering, Chemistry/Biology or similar. Preferably with at least 5 years of experience from the pharmaceutical or medical device industry or similarly related areas. Furthermore, the ideal candidate has:

  • A systematic, logical, and proactive work approach
  • A can-do attitude and is solution oriented, and you find it natural and stimulating to create new relations to various stakeholders
  • The ability to maintain a broad and strategic perspective without losing sight or interest in important details
  • Confidence and capability of handling complex production processes in a, from time to time, high work-pace without losing the overview and motivation
  • Experience with a matrix organization from a cGMP regulated areas would be an advantage
  • Proficiency in both Danish and English

About the department
IM1 Projects is responsible for the investment portfolio and execution of projects in the production facilities. The department is organized in a matrix with approx. 170 colleagues executing the portfolio, consisting of many projects in different phases. We will be driving projects worth more than DKK 500 mio. pr. year during the coming years.

You will be part of the Qualification and Usermanager team consisting of 1 Associate Manager, 8 external consultants and 8 Internal Engineering and Operation responsible. The important part of the job is to ensure qualification and validation support to the project organization matrix throughout the PEM-phases.

Working at Novo Nordisk

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 the communities we operate in.

Contact
If you want to know more about the position, please contact Associate Manager Decha Creutzfeldt at +45 3448 1984.

You can learn more about working at Novo Nordisk A/S by following this introduction website:

https://www.novonordisk.com/careers/working-at-novo-nordisk.html

Deadline

15th of January, 2023

You do not need to attach a coverletter, but please include a few sentences in your resumé about your motivation to apply. 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 25.11.2022, 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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