Contracting – Brabant Wallon The role is transversal and supports CMC Quality Leads rather than being assigned permanently to a single product. Reviewing and assessing Material of Contact documentation, including extractables & leachables data and risk assessments. Supporting complaint committee activities, including trend analysis, data challenge, deviation follow-up and preparation of solid QA positioning. Contributing to process improvement strategies for complaint management, especially in preparation for FDA inspection. Drafting or reviewing QA documents, deviations and risk-based justifications Participating in meetings with internal stakeholders (mostly in English). Challenging incoming documentation on a daily basis and providing QA decisions. The role requires autonomy, strong critical thinking and the ability to operate in a non fully stabilized environment. Minimum 5–8 years of relevant experience, the role is not suitable for junior profiles. Solid experience in Material of Contact (including Extractables & Leachables). Strong background in Complaint Management within a GMP / Pharma environment. Proven ability in deviation management, root cause analysis and CAPA -definition. Strong QA mindset and risk-based decision-making skills. Fluency in English & French. Ability to work autonomously and be force of proposal in evolving processes. Nice to have : Experience in GMP audits and inspections (FDA exposure is a plus). Experience in CMC / regulatory submissions. Data integrity or project management experience. Ability to support additional QA activities on products if capacity allows. Our offer ? Jefferson Wells offers you a permanent contra... FDA, Audit, Offering Support, VOS, GMP, Documentation, Root Cause Analysis, Trend Analysis, Risk Analysis, Quality Solutions, Drafting, Exposure, Data integrity, Decision Making, Critical thinking, Quality assurance, Inspection, CAPA, Data Challenges, CMC, Data Risk, Process Development 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! 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 – Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves ! https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be!
CRWL1_BE