Data Integrity Officer

Halden Pharma is looking for a motivated Data Integrity Officer to strengthen and further develop our data integrity program. This is a temporary position, offering a unique opportunity to gain valuable experience within quality and regulatory compliance in a highly regulated, future-oriented industry.
In this role, you will play a key part in ensuring that data from our processes and systems is reliable, complete, and fully compliant with regulatory requirements (e.g. EU GMP, FDA). You will be a driver for best practices and an important partner across the organization - working closely with colleagues in production, quality, IT, and procurement.

What you will do

• Review and support remediation of DI-related events and audit observations (internal and external)

• Conduct internal DI assessments and Gemba walks as needed

• Lead and support the Data Integrity Risk Assessment (DIRA) process, coaching process owners throughout

• Deliver training on data integrity and good documentation practices to all employees

• Communicate DI measures and follow-up actions across departments.Perform root cause analysis and risk assessments related to DI events

• Support purchasing and validation of computerized system to ensure Data Integrity Compliance

• Reviewing system requirements, specifications, validation and migration plans from data integrity perspective

• Develop, implement, and maintain DI-related standards and procedures

• Support DI-related change management activities to ensure effective implementation and control

  Who we are looking for

• A Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, Computer Science, or another relevant field

• Experience from quality, production, or regulatory work within pharma or related industries (e.g. food, medtech, chemicals)

• Familiarity with EU or FDA GMPs, ISO 9001/13485 - or strong willingness to learn

• Strong communication skills in English, both written and spoken.

• Strong analytical and problem-solving skills, with a solution-oriented mindset

• Able to work independently while collaborating effectively across departments

  What we offer

• A chance to contribute to an industry with high quality standards and real societal impact

• A varied role where you'll work with multiple disciplines and gain cross-functional exposure

• Hands-on experience that is highly valued in the pharmaceutical and healthcare sectors

• A collaborative and inclusive workplace in a growing company

Please contact Yasemin Akbaba if you have any questions related to the position: yasemin.akbaba@halden-pharma.com

Applicants will be considered on an ongoing basis.