Documentation Specialist - strengthen our GMP efforts and digital setup

Are you excited by the idea of improving GMP processes that ultimately make a difference for people with intimate health care needs? And do you want to step in to a role, where you can be part of shaping your own day – and raising the standard of our documentation setup?

In this newly created role, you will take the lead on documentation, deviations, and digital systems in a GMP-regulated facility setup across two Coloplast sites in Denmark. 

Welcome to Coloplast – and a hands-on technical support team
At our office in Humlebæk, you will join our FM Technical Team – we are four technicians and a team leader. With our various technical backgrounds, we act as a service function with a shared focus on keeping our facilities running smoothly across our two sites in Humlebæk and Mørdrup. 

You steer documentation in a technical setup with high GMP standards
Here, you will become the administrative backbone of our GMP facility support function. You will be responsible for maintaining systems, assisting across departments with various documentation tasks, and ensuring the accuracy and efficiency of all documentation processes.

You will get a varied workday, where you:

• Ensure orderliness and compliance with GDP
• Maintain and update documentation systems and digital archives, including VEEVA and network drives
• Facilitate structured problem-solving (e.g., root cause analysis) and support audits when needed
• Act as a superuser in DALUX and support documentation around maintenance and compliance (if you are not yet a DALUX expert, we will bring you up to speed)
• Drive and coordinate deviations, Change Controls, and CAPAs across departments

“Because this is a newly established role, some responsibilities will depend on your experience and skillset – and you will help shape the position as we go,” says Technical Team Manager Christian Skovhuus.

You have IT flair, technical understanding and are confident with documentation systems
You are detail-oriented, self-driven, and thrive bringing order to complexity in an ever-changing environment. 

There are several relevant paths into this role – perhaps you come from a technical background with an interest in documentation, or maybe you have had an administrative role within a regulated industry. We imagine that you bring most of the following:

• Experience from an administrative role within a technical, pharmaceutical, or GMP-regulated environment
• Some LEAN experience or interest
• Solid IT skills and the ability to work confidently in documentation systems (e.g., network drives, quality systems)
• Fluency in English, spoken and written, with the ability to produce clear and precise documentation
• Familiarity with Good Documentation Practice and an interest in supporting quality processes

Interested?
If you would like to know more about the position, please call Technical Team Manager Christian Skovhuus on +45 4911 2065. We will take candidates into the recruitment process continuously, so don’t hesitate to apply. This position will remain open until a suitable candidate has been found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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