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 QA Manager, Data Integrity and Software Validation?
If you are excited to be part of a winning team and work in an international environment, we have an opportunity for you.
The QA Manager, Data Integrity and Software Validation, who works under the direction and supervision of the Halden Site Quality Assurance Director, leads the planning and execution of software validation and data integrity activities. They are responsible for leading and managing all software validation activities within the site and working with the organization to strengthen our Data Integrity (DI) practices. They will manage projects and activities for the facility to improve product and process quality.
The position is responsible for ensuring regulatory requirements and corporate data integrity requirements for automated and manual / paper-based are understood, practices, and implemented. The position is responsible for ensuring that all areas have a good knowledge of data integrity regarding paper and electronic systems. The position holder shall develop and maintain an overall DI plan for the site, as well as ensuring systems and routines are in place to meet DI requirements.
The position holder is proactive in the use of the regulatory framework (EU GMP Annex 11 and FDA 21 CFR Part 11) and is regularly updated about the regulatory framework. The support to Halden operations will include providing daily guidance on Good Manufacturing Practices (cGMPs), leading deviation investigations, 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.
- Perform risk assessments for documents, records, equipment, and software ensuring the necessary measures are implemented to meet regulatory and corporate requirements.
- Coordinate system testing and validation to ensure that software functions as intended.
- Site champion for DI driving communication about measures, follow-up, and compliance across all departments at the factory.
- Define and deliver DI training within the factory.
- Conduct periodic review of defined software systems and critical processes.
- Assist in preparing requirements, specifications and protocols in cooperation with responsible system owner, as well as supplier(s), to ensure compliance with DI requirements.
- Establish and maintain standards, procedures, and policies related to DI.
- Ensure that new equipment and instruments are assessed and validated regarding DI requirements.
- Participate in internal and external inspections as auditor, auditee, subject matter expert, and support functions.
- Approve change controls, events, deviations, risk assessments, protocols, and reports as subject matter expert for DI and QA approval
- Subject matter expert for DI; develop and maintain URS and qualification templates evaluating DI requirements for computer systems.
- Proactively maintain routines for DI for the site
- Support organization in topics for DI and software validation
- Root cause and risk assessment with respect to DI events. Report and communicate with competence center as required.
- Drive failure investigations for events, deviations, and complaints to ensure root causes are found and appropriate corrective actions are implemented to prevent repeat non-conformances.
- Ensures that corrective measures meet acceptable standards and that documentation is compliant with all regulatory requirements.
- Provides support and input to the Q-KPI reporting tool for the site; 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.
- Any other activities as defined by site QA director.
Performance Expectations/Job Fulfillment
- No critical or Major observations from audits related to systems/processes with respect to DI that are not known and risk assessed in the site DI plan.
- Report any gaps with respect to DI as well as define needed actions.
- Timeliness in deliverables with respect to quality systems, projects, changes etc.
- Ensure that new equipment and systems are assessed and implemented in accordance with DI requirements.
- Be proactive in the internal organization regarding the oversight of different systems and define potential compliance gaps.
- Establish close relationship and collaboration with local IT department, QC, Production and Engineering.
- Author of relevant standard procedures.
- Implement and undertake training regarding DI.
- Hold specialist function within Computer Validation and DI
- Proactive relationship builder on international level within the DI network and DI Competence Center.
- Good insight and understanding of cGMP, especially EU GMP Annex 11 and FDA 21 CFR Part 11. Knowledge of GAMP.
- Qualified individual should have a Bachelors 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.
- Minimum 6 years of experience in Quality Assurance/Quality Control or related field in a regulated industry
- Minimum of 3 years software validation experience leading software validation processes
- 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
- 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
- Experience leading or working in a Quality Control Laboratory
- Experience in the pharmaceutical or medical device manufacturing facility
- Good communications skills in Norwegian and English
- Direct experience supporting and/or leading third party audits (ISO registrars, FDA or other regulatory authorities)
- Lead Auditor Certification and Training
- Operational Excellence/Six Sigma/Lean training or certifications
- Working knowledge of ISO quality management systems13485 and 21 CFR Part 820
- Project management certifications (Black Belt, Green Belt, Certified Associate in Project Management (CAPM), Project Management Professional (PMP), etc)
- Knowledge and experience with software validation
- 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