- Do you thrive on helping clients better understand the external requirements within IT compliance and IT/OT validation?
- Do you want to be part of a growing, close-knit team with a strong sense of belonging?
- Do you enjoy working in a small company with an international environment and fast decision-making processes?
Then ProjectBinder might be just what you are looking for.
Who are ProjectBinder
Our passion is to help customers improve the quality and speed of their manufacturing processes via state-of-the-art IT and automation solutions. Since 2018, we have succeeded in delivering our promise, and ProjectBinder is now made up of more than 100 colleagues from 19 different nationalities working in our offices in Denmark, Spain, and Ireland. We love being at the forefront of technological development within IT and automation, building solid relationships with our customers and ensuring our clients always get the best possible solutions. At ProjectBinder, we support each other every step of the way, and our company culture is informal, collaborative and international. Last year, we became part of the INIT group and joined forces with 700 colleagues from 8 companies within Industrial IT and automation services.
What you will do
As an IT Compliance Expert, you will be pivotal in helping our clients navigate complex regulatory landscapes and ensuring their IT and OT systems meet industry standards, compliance guidelines, and external regulations in the pharmaceutical industry.
We assist our clients with validation strategies, planning, and execution, whether they are implementing new systems, upgrading existing ones, or decommissioning outdated systems. You’ll be vital in guiding them through these processes, ensuring every step aligns with regulations like FDA 21 CFR Part 11 and EMEA Annex 11.
You’ll also familiarize yourself with various clients’ QMS systems, tailoring compliance solutions that fit their needs.
Key responsabilities
- Provide expert consulting services on IT and OT compliance during system implementation, upgrades, and decommissioning.
- Develop and review validation strategies, test plans, and test strategies to ensure compliance with industry standards such as FDA 21 CFR Part 11 and EMEA Annex 11
- Understand and apply clients’ QMS systems, integrating regulatory requirements accordingly.
- Offer clear and actionable guidance on compliance issues, ensuring our clients stay ahead in their regulatory obligations.
- Collaborate with clients and internal teams to ensure compliance throughout the project lifecycle.
What you bring
- Minimum 5-7 years of experience in IT compliance within the pharmaceutical industry
- Proven expertise with regulatory frameworks, e.g. FDA 21 CFR Part 11, EMEA Annex 11, and GAMP 5 guidelines
- Strong analytical and problem-solving skills
- Proficiency in English, both written and spoken
- Ability to understand customer needs and deliver results that exceed expectations
- Willingness to travel depending on project requirements
What is in it for you
We offer you:
- Informal and social company culture made up of supportive, fun and clever colleagues
- A collaborative team of skilled compliance colleagues ready to support you
- Extensive individual development and training
- Competitive salary, benefits, and a bonus scheme
- Flexibility to work from home when not at client sites
INFORMATIONER OM STILLINGEN:
- Arbejdspladsen ligger i:
Ballerup Kommune
-Virksomheden tilbyder:
-Arbejdsgiver:
ProjectBinder ApS, Lautruphøj, 2750 Ballerup
-Ansøgning:
Ansøgningsfrist: 27-05-2025;
Se mere her: https://job.jobnet.dk/CV/FindWork/Details/68131025-d337-4f11-a0d9-5b77f6a5c551
