Fresenius Kabi Norge AS er en farmasøytisk bedrift i vekst. Vi produserer flytende legemidler i plastemballasje til hele verden. Selskapet har de siste årene hatt en positiv utvikling og omsetter i dag for over 1 mrd. NOK. I Norge har vi i dag en fabrikk i Halden og et markedskontor Oslo, og er i overkant av 600 ansatte.
Fresenius Kabi Norge AS inngår i det tyske konsernet Fresenius SE, med hoved- kontor i Frankfurt, Tyskland. Konsernet har i dag i over 300 000 ansatte, i mer enn 100 forskjellige land rundt om i verden. For mer informasjon Se vår hjemmeside: Fresenius-kabi.com/no
We are looking for Data Integrity Officer for the QA department
Are you a Data Integrity enthusiast and ready to take the next career step? Then we have the perfect opportunity for you: Join us as Data Integrity Officer in our production unit in Halden, Norway within the QA department.
The main activities of the role will be ensuring regulatory requirements and corporate data integrity requirements for automated and manual/paper-based processes for the plant. In addition; The role will be responsible for developing and maintaining an overall data integrity plan for the site, as well as ensuring systems and routines are in place to meet data integrity requirements.
- Perform risk assessments for equipment and softwareand take necessary measures to ensure that regulatory and corporate requirements meet.
- Coordinate system testing to ensure that functions function satisfactorily.
- Communication about measures, follow-up and compliance regarding data integrity within the various departments at the factory.
- Define and perform Data Integrity training within the factory.
- Define and implement changes for instruments / equipment.
- Conduct periodic review of defined systems.
- Assist in preparing requirements, specifications and protocols in cooperation with responsible system owner / system liable person, as well as supplier to ensure compliance with data integrity requirements.
- Establish and maintain standards and procedures related to data integrity.
- Ensure that new equipment and instruments are assessed and validated regarding data integrity.
- Participate in internal inspections as auditor and expert.
- Participate in external inspections and customer visits as expert
- Approve change control, risk assessments, protocols and reports as subject matter expert for Data Integrity and QA approval for protocols and reporting with respect to compliance to requirements for Computer validation and Data Integrity topics.
- As subject matter expert for data integrity; develop and maintain URS and qualification templates evaluating DI requirements for computer systems.
- Proactively maintain routines for data integrity for the site
- Support organization in topics for data integrity
- Root cause and risk assessment with respect to Data Integrity events. Report and communicate with competence center.
Other tasks may be assigned to the position when needed.
- Bachelor’s Degree in Science in: Computer Science, Chemistry, Biology, Pharmacy, Engineering, Business, Mathematics, or technical field with emphasis on statistical and problem-solving skills. Advanced degree preferred.
- Working experience in Quality Assurance/Quality Control, Software Testing/Validation, or related field in a regulated industry
- Working Experience with EU or FDA cGMPs
- 21 CFR part 211 or Part 820, ICH Q7, EU Pharma GMPs, or ISO13485 preferred
- AS9100 or TS16969 Quality Systems will also be considered
- Superior leadership, facilitation, and communication skills
- Direct experience supporting and/or leading third party audits (ISO registrars, FDA or other regulatory authorities)
- Working knowledge of ISO quality management systems13485 and 21 CFR Part 820
- Experience using Sparta Trackwise and/or SAP.
- Good report writing and reviewing skills
- Positive mind-set and an including attitude
- Excellent communication and interpersonal skills
- Ability to build good relationships
- Ability to work in a structured, systematic and dynamic environment
- Proactive and goal oriented
- Organized and quality oriented
- Ability to make decisions
- Excellent verbal- and written communication skills in Norwegian and English
If you are interested to go on this journey with us, feel free to apply for this position!
Please apply before the 20th of October 2021.
For more information about the position, please contact: Aaron.Snyder@fresenius-kabi.com. Applicants will be considered on an ongoing basis.