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IT Validation Lead

Anonym virksomhed / Fuldtid

The company have a passion for improving patients’ lives all over the world. Will you help us bring that passion to life? Would you like to further develop your expertise within validation and quality control? We are looking for a skilled IT Validation Lead to help drive the digital transformation– join us today!

Play your part in System Operations and Compliance

We are a dedicated team of 14 people anchored in Research and Early Development IT (R&ED IT). We are responsible for developing, implementing, validating, and operating more than 30 regulated laboratory IT systems that are used within the non-clinical and clinical early development area of the company and we are now expanding. From this role as IT Validation Lead you will participate a cross organisational Agile Release Train within the system GlobalLIMS.

We are all working together as part of an agile-, collaborative- & learning work environment, where professional integrity and shared responsibility are key. R&ED IT is part of Digital, Data & IT (DD&IT), – a global community of 2100+ colleagues, driving digital, data, and IT, to support digital transformation and innovation in all parts of the value chain – from idea to patient.

IT Validation Lead

As a validation lead, you will be responsible for defining the validation strategy, validation planning, and reporting concerning a specific implementation or upgrade of an IT system with GxP (healthcare) impact. You will work closely with the product owners, Line of Business (LoB), and other stakeholders to understand the scope of validation and act as liaison with LoB QA and ITQA.

This is a job for those who are excited to work with technologies, validation, testing, and quality control in agile IT projects. Your key tasks will include:

  • Participation in large-scale IT projects as the validation expert thus responsible for the execution of validation and quality control activities
  • Taking responsibility for all validation activities for the project(s) e.g., planning, documentation, coordination, and reporting, and ensuring that these are executed effectively.
  • Helping develop and optimize our approach to validation and quality control work, ensuring we test and validate the right things at the right level, supporting a risk-based approach to testing.
  • You will be responsible for performing various assessments such as Supplier Assessment and IT risk assessment or facilitating the workshops for these activities.
  • You ensure the validated state of the system(s) by performing periodic reviews, addressing deviations, creating and maintaining system documentation and instructions in corporation with the system managers and IT
  • responsible when needed
  • Ensuring that systems follow relevant internal and external regulatory requirements.
  • You will also participate in audits and inspections including finding solutions to compliance gaps identified during audits and inspections
  • Help development teams develop and maintain test plans, test scripts, and user acceptance tests and manage the execution of test plans

What are we looking for?

You are proactive and thrive in a challenging, dynamic, and ever-changing environment. You can handle several tasks at a time and keep an ongoing focus on results. You are open-minded, positive and collaborate well with external parties, customers, vendors, and consultants.

  • A Bachelor’s degree or similar graduate degree within relevant fields
  • +2 years of experience within IT Validation from the pharma industry or other regulated industries.
  • You are experienced in working with large-scale projects, preferably working in an agile manner.
  • You are process-oriented and have good documentation skills
  • You are familiar with change management

The company don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Recruitment assistance

This recruitment process, is assisted by Capax Recruitment. For additional information about the position, please contact Xenia Reimers Rosiak at xrr@capax.dk

Applications will be screened after the expiration date, and interviews will be held thereafter.

To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

The company 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.

 

 

Jobinfo

Segment:

Region:

IT

Hovedstaden

 

 

Segment: IT
Region: Hovedstaden