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Global serialization lead sap/dscsa l5 (remote eu)

Bruxelles
Real
Publiée le 3 juin
Description de l'offre

Ph3About the Role /h3 pWe are supporting a leading organisation in the bpharmaceutical industry /b undergoing a key bdigital supply chain transformation /b, focused on implementing a bSerialization Level 5 system /b to ensure compliance with bUS DSCSA regulations /b. /p pThis is a bhigh-impact role /b within the Digital Technology function, requiring a hands‑on functional expert capable of bridging bIT, Quality, Supply Chain, and external vendors /b in a global environment. /p pThe solution is an bindustry‑standard serialization platform (not custom‑built) /b that must integrate seamlessly into an existing ecosystem, including bSAP ATTP (Level 4) /b and established validation frameworks. /p h3Responsibilities /h3 ul liAct as the bFunctional Lead /b for the Level 5 serialization system implementation /li liCollaborate closely with the bsolution vendor and system integrator /b to understand capabilities and constraints /li liCoordinate cross‑functional stakeholders across: ul liIT Validation /li liQuality Assurance (Digital Business) /li liGlobal Supply Chain /li liFunctional System Owners /li /ul /li liLead and contribute hands‑on to CSV deliverables: ul liURS, FRS, DS, FRA, IQ/OQ/PQ /li /ul /li liEnsure alignment with bSOPs, validation standards, and documentation frameworks /b /li liPlan, track, and coordinate bvalidation and delivery activities /b /li liActively participate in project governance, escalating risks and issues when needed /li liWork in close collaboration with a bbusiness‑side project manager /b /li /ul h3Profile /h3 ul liMinimum b8+ years of experience /b in bpharma / life sciences (GxP‑regulated environments) /b /li liProven hands‑on expertise in bserialization systems (L3‑L5) /b /li liStrong experience in bComputerized System Validation (CSV) /b /li liExperience with at least one of the following: ul libSAP ATTP /b /li libSAP ICH /b /li libTraceLink or other Track Trace platforms /b /li /ul /li liSolid understanding of: ul libUS DSCSA regulations /b /li libGS1 standards EPCIS /b /li /ul /li liExperience in bsystem integration projects /b, particularly bLevel 4–Level 5 /b /li liHands‑on experience with validation documentation (URS, FRS, DS, IQ/OQ/PQ) /li liAbility to operate as a bFunctional Lead /b (not purely Architect or Project Manager) /li liStrong stakeholder management across bIT, Quality, Supply Chain, and Vendors /b /li liExcellent communication skills in bEnglish /b /li /ul h3Nice to Have /h3 ul liExperience with bSAP ATTP Level 4 implementations /b /li liPrior involvement in bUS‑market serialization projects /b /li liExperience working in bglobal, cross‑functional teams /b /li liExposure across multiple serialization levels (L3, L4, L5) /li liExperience delivering serialization solutions for the US market /li liExperience in cross‑functional, international project teams /li /ul h3Project Details /h3 ul libStart Date: /b ASAP (target June 2026) /li libDuration: /b Until December 2026 (extension likely into 2027) /li libWorkload: /b ~50% (flexible depending on profile) /li libLocation: /b ul liRemote within EU time zone /li liOR Belgium‑based (1 day/week on site in Walloon Brabant) /li /ul /li /ul /p #J-18808-Ljbffr

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