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
Are you our new Quality Assurance Pharmacist?
If you are excited to be part of a winning team and work in an international environment, we have an opportunity for you.
The Quality Assurance Pharmacist, is an entry level position that works under the direction and supervision of the Halden Quality Assurance Manager – Product Release, supports the planning and execution of batch review and release activities. They are responsible for supporting a team of Qualified Persons which directly manage all batch review, approval, and release activities. They will participate and support projects and activities for the facility to improve product and process quality.
They will analyze quality issues (such as events, deviations, complaints, lab out of specifications (OOS), etc) to identify the needed corrections and corrective actions. The Quality Assurance Pharmacist will also be a key resource in identifying and developing best practices for process improvement, problem solving, and driving customer satisfaction.
The support to Halden operations 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, Purchasing, Engineering, Regulatory Affairs, etc.) and other internal sites (sister manufacturing sites and contract manufacturers) to resolve quality issues.
- Support a team of qualified persons within the Halden plant helping them manager their workload by handling events and deviations.
- Manage failure investigations for events, deviations, and complaints to ensure root causes are found and appropriate corrective actions are implemented to prevent repeat non-conformances.
- Work with team members to ensure that corrective measures meet acceptable standards and that documentation is compliant with all regulatory requirements.
- Communicate with customers and resolving all customer inquiries.
- Support other event and deviation owner to ensure investigations are complete and documentation stands on its own during external review.
- Collaborates with internal groups to ensure quality standards are in place and improvements are implemented according to defined plans.
- Lean, understand, model, and champion current Good Manufacturing Practices behaviors within the facility.
- Provide support and input to the Q-KPI reporting tool for the site.
- Support and communicate with the site at the Quality Circle meetings.
- 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
- Take on additional responsibilities as defined by the site QA Director.
Expectation of achievement
- Support the QPs by helping them manage their workload and taking over management of events and deviations.
- Event and deviations are resolved quickly leading to improved batch release timelines
- Quality issues are evaluated and reported in a timely manner to management when a field action or field alert might be required.
- Communication and cooperation with customers, authorities, notified body and suppliers is professional, and any requests are responded to in a timely manner.
- Timely support to projects according to agreed timelines
- KPIs are within defined limits and action is taken when expectations are not met.
- Qualified individual should have a Bachelors Degree in Science in: Chemistry, Biology, Pharmacy, Engineering, Business, Mathematics, or technical field with emphasis on statistical and problem solving skills. Advanced degree preferred.
- Solid leadership, facilitation, and communication skills
- Understanding of problem solving or continuous improvement methodologies
- Awareness of ISO Quality Management Systems
- Excellent communication and interpersonal skills
- Ability to work independently across multiple organizations
- Good report writing and reviewing skills
- Experience working in a Quality Control Laboratory
- Experience in the pharmaceutical or medical device manufacturing facility
- Good communications skills in Norwegian and English
- Exposure to process and/or software validation methods
- Operational Excellence/Six Sigma/Lean training or certifications
- Working knowledge of ISO quality management systems13485 and 21 CFR Part 820
- Experience using Sparta Trackwise and/or SAP.
- Positive mind-set and an including attitude
- Ability to build good relationships
- Ability to work in a structured, systematic and dynamic environment
- Good communication- and cooperation skills
- Proactive and goal oriented
- Organized and quality oriented
- Ability to make decisions
For more information about the position, please contact QA Director Wayne Aaron Snyder (Aaron.Snyder@fresenius-kabi.com)
Søknadsfrist 31. Juli 2021