HP Halden Pharma AS
Svinesundsveien 80, 1788 Halden, 1788 Halden
Om jobben
Type ansettelse
Engasjement, heltid 100%
Arbeidsspråk
Engelsk
Antall stillinger
1
Søk senest torsdag 14. august
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.
Om bedriften
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
Sektor
Privat
Nettsted
https://halden-pharma.com/
Annonsedata
Stillingsnummer
5ed35710-1541-427b-b9d1-2141830c0f24
Hentet fra
FINN
Referanse
418938077