QA IT Compliance Specialist

Be part of a company that matters
SSI Diagnostica Group is a global and vertically integrated in vitro diagnostics (“IVD”) company focused on gastrointestinal, respiratory and blood borne diseases with well proven products spanning from polyclonal and monoclonal antibodies, antisera, culturing, and rapid diagnostics using a broad range of innovative technologies.

The Group has a strong footprint in many geographies serving its customers (microbiology / hospital labs, reference / CDC labs, vaccine producers, IVD and NGOs) through a comprehensive global distribution network and via direct sales force in US and Nordics. The organization has 500+ employees spread across four sites in US - San Diego and Virginia, China - Beijing and Denmark - Hillerød (HQ).

SSI Diagnostica Group is currently going through significant changes from local IT- systems and solutions in to global, starting with our core ERP-system. The ERP-system chosen (Dynamics 365 F&O) is a cloud-based Evergreen system.

Would you like to be an essential part of this global development in an exciting international company, that insists on delivering better and faster microbiological diagnostics worldwide, then perhaps you are our new colleague.

The position
As Global QA IT Compliance Specialist with extensive Computer system validation skills, you will be involved in one or more projects, working closely with colleagues in QA, IT and stakeholders across the global company to ensure the implementation of new IT solutions and software.

Your responsibilities will include:

• Overseeing validation activities in relation to IT compliance for projects and supporting validation of new and updated software, both locally and worldwide (such as ERP, Label system, Quality Management System, with focus on ensuring that the system is validated and fulfills the requirements whether it is FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, IVDR etc.
• Creating Validation and test plans for IT related tasks; approving documentation in collaboration with stakeholders, RA and QA.
• Reviewing and overseeing various documents related to validation and qualification to ensure compliance with current GMP/GxP rules and guidelines as well as maintaining product quality
• Updating/developing system design documents (Functional Specification, Design Specification for example), Standard Operating Procedures and guidelines for the system operational processes
• Working with incident and deviation management as well as preparation of change requests related to software, applications and validation.
• Ensure that implemented systems, hereunder the ERP system remains validated after go live.

Qualifications
To thrive and succeed in this role, we imagine you have:

• At least a bachelor’s degree within IT, electronic engineering or any other relevant field
• A great passion for working with IT compliance, system operation and/or automation, as well as a natural curiosity for new technologies and opportunities.
• A proven experience with validation and qualification for IT systems, ERP systems (Preferred Microsoft based ERP systems) and/or equipment ideally obtained within a regulated manufacturing environment
• Knowledge about ISO 13485, FDA 21 CFR Part 11, FDA 21 CFR Part 820, IVDR and other GxP standards.
• Have good communication and teamwork skills in Danish and English
• Proficiency in English, spoken and written

We offer
An exciting full-time position in a company with competent colleagues in an informal environment.

You will get good development opportunities, as we emphasize that the individual employee can influence his or her job. You will work in an innovative organization with a good working environment, flexibility, canteen scheme, health insurance and pension scheme.

You will work in a company that is growing, and which products makes a positive difference in the world.

Department: Herredsvejen 2, Hillerød

Application deadline: 24 Sep 2024