ul liProvide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. /li /ul h3Purpose /h3 ul liProvide independent quality oversight and documented challenge of OT CSV and data-integrity remediation. /li /ul h3Revised responsibilities /h3 ul liReview/challenge scope, risk rankings, test strategy, deviations, validation reports and CAPA evidence. /li liVerify independence from authors/executors and identify unresolved GMP risks. /li liReview DI controls and critical electronic-record lifecycle evidence with the DI specialists. /li liPrepare QA-approved inspection narratives and coach technical SMEs; escape critical deficiencies. /li liRecommend acceptance/rejection; sign as approver only if documented Lonza delegation permits (decision D05). /li /ul h3Must-have requirements (recruitment) /h3 ul liSubstantial independent QA oversight of computerized systems in GMP (15+ years preferred; 10+ with strong oversight record flagged for D09). /li liDirect FDA inspection experience (front room or back room) on computerized system or data integrity topics. /li liExpert knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5 (Second Edition) and data integrity guidance (FDA, MHRA, PIC/S); QA experience on OT/automation systems, preferably DeltaV. /li liWilling and able to travel to Visp 2 days per month. Fluent English. /li liNice-to-have: FDA 483/warning-letter remediation, biologics manufacturing, qualified GMP auditor, German. /li liCV keywords: independent QA review, FDA inspection, 483, warning letter, Part 11, Annex 11, PIC/S, MHRA DI, DeltaV, CAPA. /li /ul h3Critical competencies /h3 ul liIndependent GMP QA CSV oversight and direct FDA inspection exposure; senior profile (15+ years preferred, D09 pending). /li liExpert OT computerized systems, DeltaV/batch/historian control risks, Part 11, Annex 11, GAMP 5 and DI guidance. /li liAbility to challenge weak risk justifications, insufficient evidence and ineffective CAPAs. /li /ul h3CV screening knock-out criteria (screening w/c 19-Oct-2026) /h3 ul liNo direct FDA inspection exposure. /li liExecution-only CSV background without an independent QA oversight role. /li liNot available to start between 2-Nov-2026 and 1-Dec-2026. /li /ul h3Minimum deliverables /h3 ul liQA review log, challenge register and disposition decisions. /li liDocumented review of critical validation/DI packages and inspection readiness evidence. /li liEscalation log and recommended acceptance/residual-risk statements. /li /ul pWe believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives. /p #J-18808-Ljbffr
QA CSV Engineer in Raron Arbeitgeber: SGI
Als führendes Unternehmen im Finanzdienstleistungssektor in Deutschland bietet unsere Organisation nicht nur eine spannende Rolle als SailPoint Engineer, sondern auch ein dynamisches Arbeitsumfeld, das Innovation und Zusammenarbeit fördert. Wir legen großen Wert auf die berufliche Weiterentwicklung unserer Mitarbeiter und bieten zahlreiche Schulungs- und Aufstiegsmöglichkeiten, um Ihre Karriere voranzutreiben. Darüber hinaus profitieren Sie von einer positiven Unternehmenskultur, die Vielfalt schätzt und ein ausgewogenes Verhältnis zwischen Berufs- und Privatleben unterstützt.
