Contracting – Brabant Wallon As a Quality Process Data Owner, you will have to: Provide stewardship and functional management to lead the implementation of strategies for all the company's GxP and non-GxP QA processes. (Veeva Source Quality QMS, …) Be the process data owner for Source QMS (Veeva Source Quality QMS). Ensure the use of the platform on a global basis in collaboration with other Quality groups and applicable business areas. Ensure that the platform is maintained in a state of compliance (validation, current procedures, etc.). Take a leadership role in bringing together the QMS key users on a periodic basis. Accountable for the inspection and audit readiness of the platform under the scope of the Quality Digital industrialization team. Monitor industry trends & directions and discuss possible impact on internal strategies. Drive long term strategic planning for platform under scope of the Quality Digital industrialization in collaboration with stakeholders. Proactively seek for continuous improvement and develop and share best practices solutions and processes in terms of organization, positive attitude, harmonized work style and customer focus Establish and build a network with the company key stakeholders and external partners in relation to Quality Systems. Responsibility and accountability to maintain and enhancing transversal cooperation between Business process Owners, Digital industrialization team, IT and/or Vendor. Act as a facilitator and contributor for the definition of global communication needs for the different owned systems. Establish and develop KPIs and metrics is collaboration with the Quality Dashboarding responsible. Write, review and/or approve as appropriate SOPs, Change Control, Complaints, Deviations, Investigation, and/or CAPA, trainings as they relate to the computerized system in charge. Bachelor's Degree 5 or more years of experience in administration or maintenance of electronic Quality management system or comparable electronic tools (preferably in the biosciences or pharmaceutical industry) Fluent in French, intermediate in English Knowledge of GxP principles of the ICH Guidelines and FDA regulations. Excellent ability to analyze information, take initiative and strive for lean processes, efficient and effective training and thus, enhance quality, performance, and compliance. Good knowledge of validation requirements for computerized systems in the pharmaceutical environment In-depth knowledge of QMS processes (complaints, deviations, audits…etc) Excellent influencing and leadership skills particularly within multi-cultural and virtual environments Must possess Strong communication, presentation and negotiation skills Jefferson Wells offers you a permanent contra... Customer Oriented, FDA, Team Leadership, Dashboarding, Pharmaceuticals, Administration, KPI, Communication, Maintenance, Strategic Planning, Strategies, Business, Audit, ICH Guidelines, Virtualenv, Validation, Investigations, Inspection, Regulation, Pharmaceuticals, Stewardship, Training, Data Processing, Quality systems, Veeva, Networks, Metric, Leadership, Best Practices, Lean Processes, Bioscience, Strategy Execution, Accountability, Change Control, Business Process, GxP, Quality assurance, CAPA, Initiative taker, Negotiation, Industrialization Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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