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Operational quality manager m/v/x...

Anvers
Actiris
Publiée le 27 mai
Description de l'offre

Beschrijving van de functie At SGS, you can choose.First of all, out of our various vacancies. However, SGS also givesyou another choice. Do you choose to expand or to enrich? We arenot only looking for colleagues who can go into depths of theirdiscipline. We are equally as much looking for colleagues who wecall ''connectors'', people who can connect our diversity to ourservices. To each other. And this way, enrich our business. SGS isthe world''s leading inspection, verification, testing andcertification company. We''re also the worldwide benchmark forquality and integrity. And that makes us very proud. This can onlyhappen thanks to more than 90 000 colleagues worldwide, with 1650employees in Belgium only. Our employees give 110% of themselvesevery day, divided over all expertises, branches and cultures. Ourcoworkers build their own way inside the company, the services andthe expertise. The Quality Assurance Department is an independentdepartment within SGS Pharma. It is responsible for the QualityManagement System, which covers all quality documents, training andqualification, resolution and documentation of non conformances,auditing activities and dedicated quality support to alloperational teams (i.e. Clinical Pharmacology Unit (CPU), BusinessDevelopment and Support, Clinical Operations, Biometrics andMedical Safety & Regulatory). We are currently looking for anOperational Quality Manager. As Operational Quality Manager (OQM)you are welcomed in a smaller, amiable, and enthusiastic QA teamwhere you will have day to day interaction with other QA experts inthe field, such as other OQMs, Quality Compliance Managers,Auditors,. As OQM, you will be an indispensable partner of theoperational teams specifically at our CRO in the management oftheir part of the quality system. As such, you will gain furtherinsight into the CRO activities involved in the conduct of clinicaltrials for pharma and biotech companies from start to finish. Yourresponsibilities: Your main responsibilities are the following:Collaborate with the assigned operational teams at the CRO toimprove quality and maintain high quality standards throughout theorganization by: Developing and maintaining operational quality(SOPs, WIs, CDs, manuals and various guidance documents) andpersonnel documents Supporting the teams by providing additionalexplanation on topics relating to quality documents/processimprovements, development of trainings (eLearnings, classroomtrainings) together with the QA training department Initiateprocess improvements / efficiencies were needed Guide the teamsthrough the non conformance management process by assisting in riskassessment of non conformances, Root Cause Analyses and formulationof CAPA Plans Assist the teams in performing their daily work in aconsistent and efficient way Participate in / facilitatecross functional discussions and working groups related to anyaspect of quality at the CRO, to create or optimize

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