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
Sr. Laboratory Quality Engineer
The Sr. Laboratory Quality Engineer, who works under the direction and supervision of the Halden Manufacturing QA Manager, leads the planning and execution of projects and activities for the facility to improve product and process quality. They will analyze quality data (such as events, complaints, deviations, OOSs, process capability, etc.) to identify and correct quality issues. The Sr. Laboratory Quality Engineer will also be a key resource in identifying and implementing best practices for process improvement, problem solving, and driving customer satisfaction.
This individual is responsible for supporting the Fresenius Kabi’s pharmaceutical quality control (QC) laboratory in Halden Norway. They will lead the quality initiative within QC. This includes responsibility for leading investigations into events/deviations, reporting quality system metrics, leading Corrective Action and Preventive Action (CAPAs) investigations and driving improvement activities. The support to QC will include providing daily guidance on Good Manufacturing Practices (cGMPs) and effective risk management. This position is hands-on in a fast-paced environment which interacts with multiple functions (QC, Production, Supply Chain, Engineering, Regulatory Affairs, etc.) and other internal sites (sister manufacturing sites and contract manufacturers) to resolve quality issues.
- QC laboratory presence to ensure compliance with locally established procedures and processes:
- Perform production walkabouts
- On the spot QA decision taking & trouble shooting
- Document checks in oversight manner, lab records, Logbooks etc. (Review logbooks & quality relevant documents)
- Shop floor assessment of fulfilment of Data Governance principles
- Continuously improve and update documentation and work routines
- Support and mentor laboratory operators, technicians, supervisors, and managers in quality related aspects of their duties:
- Support raising of incidents & deviations in KabiTrack
- Support OOx investigations and root cause analysis
- Support change control process
- Check efficiency of actions (CAPAs & Changes, Gemba)
- Serve as contact person to discuss, evaluate and decide on quality related topics
- Participate in risk assessments
- Drive failure investigations to ensure root causes are found and appropriate corrective actions are implemented to prevent repeat events/deviations.
- Execute effective review and assessment of events, deviations, and CAPAs.
- Review records, procedures, work instructions, forms etc. to ensure that they are accurate, complete and compliant with the process and with the requirements of the quality management system / GMP.
- Review and approve event investigations, initial impact assessments, and disposition.
- Determine adequacy of acceptance activities and make necessary improvements
- Support change management activities to ensure process changes are managed and approved effectively.
- May supervise additional quality personnel to ensure quality objectives are met.
- Drive continuous improvements of the quality program.
- Work active to improve right first-time batches
- Training of personal in cGMP/Good Documentation Practices, etc.
- Other tasks may be added the position if necessary.
- Demonstrate behavior consistent with the Company's Code of Ethics and Conduct. Ensure that direct reports) are trained and evaluated on their knowledge and adherence to the Company's values, Code of Ethics and Conduct, and applicable compliance policies
Qualified individual should have a bachelor’s degree in Science in: Engineering, Chemistry, Biology, Pharmacy, Business, Mathematics, or technical field with emphasis on statistics and problem-solving skills. Advanced degree preferred
- Minimum 6 years of experience in quality assurance or related field
- Minimum 3 years QC experience
- Quality audit experience (or supplier auditor)
- Direct working experience with EU or FDA cGMPs:
- 21 CFR part 211 or Part 820, ICH Q7, EU GMPs, or ISO13485 preferred
- AS9100 or TS16969 Quality Systems will also be considered
- Superior leadership, facilitation, and communication skills
- Demonstrated implementation of continuous improvement methodologies
- Working knowledge of ISO quality management systems
- Exposure to process and/or software validation methods
- Excellent communication and interpersonal skills
- Ability to work independently across multiple organizations
- Good report writing and reviewing skills
- Good Norwegian and English knowledge
- Detailed understanding and knowledge of Data Integrity
- Lead Auditor Certification and Training
- Operational Excellence/Six Sigma/Lean training or certifications
- Project management certifications (Black Belt, Green Belt, Certified Associate in Project Management (CAPM), Project Management Professional (PMP), etc)
- Experience using Sparta Trackwise
- Experience using SAP
For more information about the position, please contact Manufacturing QA Manager Wenche Signebøen, tel. 95523477 or email: firstname.lastname@example.org.