Requirements: English
Company: CareerWallet
Region: Braine-l''Alleud , Wallonia
Contracting Brabant Wallon Audit Management Conduct audits of Study Reports, Study Phase Reports, Study Plans and Study Plan Amendments to assure the applicable OECD guidelines, SOPs and the Analytical Methods have been adhered to and that reported results accurately reflect the raw data according to SOPs and associated controlled documents Archive audit documentation per SOPs; e.g., issued audit reports, supporting documentation, QAS, additional documents as expected according to SOPs and associated controlled documents Follow up with CAPA owners to manage actions to an on-time completion according to SOPs and associated controlled documents Issue Management Contribute to investigations of non-compliance to areas of research and development operations which are within the scope of the Good Laboratory Practice (GLP) Compliance Program, the Good Clinical Practice (Laboratory) Guidelines (GCP Lab), and relevant Human Tissue regulations according to Policies and Procedures When requested, facilitate discussions with internal stakeholders and SME network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance to according to Policies and Procedures and OECD Principles. Inspection Readiness Support Provide support during GLP/GCP inspections and investigations conducted by international and national authorities or business partners according to Policies and Procedures as requested Other Responsibilities When requested, represent R&D and PV Quality at interdepartmental, project and study team meetings as an individual contributor When requested, provide guidance to other members of the R&D and Pharmacovigilance Quality team. Bachelor''s degree in Sciences Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results Skilled in influencing others within a global matrix organization and driving informed decisionmaking Capable of prioritizing and focusing on critical issues using a risk-based approach Manage quality and compliance issues with diligence, rigor, transparency and timeliness Demonstrate strong analytical skills with experience in analyzing and synthesizing complex data Fluency in French & English Jefferson Wells offers you a permanent contra... Issue Management, Provide Guidance, Documentation, Influential Skills, Science, R&D, Driving, SME, Business, Audit, Engagement, Decision Making, Audit Report, Laboratory Work, Matrix Management, Projects, Inspection, Investigations, Regulation, GLP, VOS, Networks, Archive, R&D, Audit management, Analytical methods, QAS, Operations, Pharmacovigilance, Motivate Employees, CAPA 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 carriretips op StepStone.be! Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job! https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be! La version originale de cette offre d''emploi est disponible sur stepstone.be Crez maintenant votre Job Agent sur StepStone et trouvez le job de vos rves ! https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrire sur stepstone.be!
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