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.

HP Halden Pharma AS, strategisk plassert ved Norges største innfartsåre, er en av de største og mest avanserte sterile produksjonsfasiliteter i Nord Europa.

Dette «state-of-the-art» anlegget produserer IV poser, plastampuller og vials ved hjelp av en «blow-fill-seal» teknologi og andre farmasøytiske doseringsformer.

Anlegget var ikke bare en hjørnesteinsbedrift for den tidligere eieren Fresenius Kabi i Norden, men henvender seg allerede til andre fremtredende farmasøytiske kunder som kontraktsprodusent.

I Norge, har vi nå et anlegg i Halden med rett over 650 medarbeidere.

For mer informasjon, vennligst se vår hjemmeside: halden-pharma.com