Darum lohnt es sich
The ideal candidate brings strong expertise in GxP compliance, validation methodologies, and computerized systems, along with the ability to operate in complex, cross-functional projects. /ppThis position is part of a blong‑term project based in the Canton Bern (Switzerland) /b and requires b100% on-site presence. /b /ph3Responsibilities include, but are not limited to: /h3ulliExecute and manage the CSV lifecycle in accordance with GxP and regulatory requirements /liliSupport and drive Computer Software Assurance (CSA) implementation /liliDevelop and maintain Requirements Traceability Matrices (RTM) /liliPerform and review risk assessments to ensure compliance and quality standards /liliDefine and execute test strategies, including planning and coordination of validation activities /liliProvide validation support for MES, DCS, and PCS systems /liliCollaborate closely with QA, IT, and business stakeholders /liliEnsure adherence to GAMP 5, FDA, and EU regulatory guidelines /li /ulh3Required Qualifications: /h3ulliProven experience in CSV within Pharma, Biotech, or Life Sciences /liliStrong knowledge of GxP, GMP, and regulatory frameworks /liliHands‑on experience with systems such as MES, DCS, or PCS /liliSolid understanding of CSA principles and modern validation approaches /liliGAMP 5 training/certification required /liliExcellent analytical and documentation skills /liliFluent in German and English /li /ul /p #J-18808-Ljbffr ppAre you ready to join a bworld leader /b in the exciting and dynamic fields of the bPharmaceutical and Medical Device /b industries? bPQE /b bGroup /bhas been at the forefront of these industries bsince 1998 /b, bwith 40 subsidiaries /band more than b2000 employees in Europe, Asia and the Americas. /b /ppWe are seeking an bexperienced CSV (Computer System Validation) Consultant /b to support validation activities within regulated Pharma and Life Sciences environments.
