State/Province: Region Hovedstaden
IT Compliance Lead
Anonym virksomhed / Full time
Would you like to further develop your expertise with IT compliance in a GxP regulated area? Do you enjoy a balance between technical tasks, quality tasks and strategic responsibility? And do you enjoy working in an open, dynamic, and social atmosphere with a strong focus on technical and scientific skills. Apply now!
About the department
In their department Discovery & Development IT Solutions they are responsible for operation & maintenance, development and upgrades for more than 30 regulated laboratory IT systems used within the non-clinical and clinical research and development area.
They are a dedicated team of 14 people – all working together as part of an agile, collaborating & learning work environment, where scientific integrity and shared responsibility is key. Their team is part of the company’s Global IT and they work closely together with their IT colleagues in Bangalore.
You will be part of a team that works to implement, validate, and support Windows-based Laboratory IT systems. They have a natural desire to always look for smarter ways of doing things and are always working to contribute to improving the company’s standards and services.
- Lead compliance work streams across projects as responsible for end-to-end quality and compliance activities ensuring IT Security and GxP Data Integrity
- Work collaboratively across functions with Quality, IT, Business and vendors to plan, coordinate and execute computer system validation activities
- Perform risk-based validation of GxP systems, develop validation documents in accordance with corporate processes
- Be responsible for the development and delivery of complete validation packages, incl. IT Risk Assessment, Requirement Specifications (e.g. URS), Validation Plan/Report (VPL/VR) Installation/Operational/Performance Qualification Protocol/Report (xQP/R), Traceability matrix (TM), Operation and Maintenance SOPs, etc
- Facilitate verification and validation activities including test execution, documentation review and approval
As a person you have solid experience about the GAMP framework. You are a team player, and you are experienced in working with and running bigger projects.
Further you have:
- A strong Pharma / Life Sciences compliance background and experience with working with validated computer systems
- Minimum 4+ years of pharmaceutical Quality Management and GxP system validation experience
- Experience working with the guidelines provided by the global regulatory agencies and authority agencies such as FDA and MHRA in areas including, but not limited to, GxP, 21 CFR Part 11, GAMP
Excellent communication skills in Danish and English, written and orally
At this company, they don’t wait for change. They drive it. They are a dynamic company in an even more dynamic industry, and they know that what got them to where they are today is not necessarily what will make them successful in the future. They embrace the spirit of experimentation, striving for excellence without fixating on perfection. They never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – they are all working to move the needle on patient care.
In this recruitment process, the company is assisted by Capax Recruitment. For additional information about the position, please contact Rikke Barlund Hansen at email@example.com
Please apply before October 10th 2022.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
They commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We recognize that it is no longer good enough to aspire to be the best company in the world. They need to aspire to be the best company for the world and They know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. They are therefore committed to creating an inclusive culture that celebrates the diversity of their employees, the patients they serve and communities they operate in. Together, we’re life changing.