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Supervisor QC Operations EM UM

Prothya Biosolutions

pAs ourb Supervisor QC Operations EM UM /b you are responsible for environmental and utility sampling and reporting and you will play a critical role in ensuring compliance of the utilities and environment in the manufacturing of pharmaceutical products. /pbrAls u geïnteresseerd bent om op deze vacature te solliciteren, zorg er dan voor dat u voldoet aan de volgende, hieronder vermelde vereisten.brRoles and responsibilitiesbrullibr/liliManagement of EM UM sample staff and EM UM Officers including completion of performance feedback, reviews and disciplinary action.br/liliEnsure sampling and reporting is initiated and performed in a timely manner and adhering to quality standards.br/liliDraft and edit SOPs as needed.br/liliResponsible for insuring completion of required instrumentation maintenance and calibration.br/liliCollaborate with cross-functional teams, including Quality Assurance, Manufacturing, Product Support and Production to support product release and investigations.br/liliAssist in the development, optimization, and validation of EM UM methods and procedures to ensure robustness, accuracy and reproducibility.br/liliTake GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key standard operating procedures such as procedures for events, out of specifications and good documentation practice and applicable ISO/EP standards.br/liliReview of paperwork for compliance.br/liliStrong understanding of trending and microbiological troubleshooting.br/liliParticipate in continuous improvement of the department and site as a whole; record keeping, EM UM processes, site safety, etc.br/liliConduct periodic work meetings with the employees of the department and hold them accountable for results.br/liliResolution of technical problems in accordance with policies and procedures.br/liliProviding orientation and training of testing personnel.br/li /ulbrYour profilebrullibr/liliBachelor education or working knowledge at Bachelor level in the field of pharmacy, microbiology or (bio)chemistrybr/lili5 years of experience within EM among which at least 3 years of people leadership experience and performance managementbr/liliExperienced with monthly and quarterly reportingbr/liliStrong affinity with manufacturingbr/liliKnowledge of GMP guidelines with regard to quality control and validationbr/liliDevelopments in the field should be followed and explored for consequences and/or usefulness for QCbr/liliConversational Dutch and excellent English language skills.br/li /ulbrOur offer:brullibr/liliEmployment for 40 hours per week (less can be discussed).br/lili8.33% end-of-year bonus and 8.33% holiday allowance.br/liliA personal training budget of €2,100 every three years to foster professional growth and development.br/liliContribution to travel expenses from the first kilometer.br/liliExcellent accessibility by public transport and private parking available.br/liliA pension plan with Zorg Welzijn, providing security for your future. xgiwjmb br/liliA dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.br/li /ulbr

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