Senior Quality Specialist & Data Integrity Officer at Fisher Clinical Services GmbH

Quality reference for IT in regard to Validation of IT systems; Review and approve equipment qualification/requalification & computerized system validation documentation; Qualification & validation operations coordination; Periodical review, audit trail review coordination and approval; Author CSV activity templates; Approve CSV SOPs, change requests and deviations; Approve and coordinate production system's data change control; Ensure compliance with Data Integrity requirements; Participation as internal auditor for inspections; CSV QA representative in client audits; Data Integrity Officer (Monthly DI Metrics, DI Surveillance, Annual DI Plan, DI Moments and DI Governance Team coordinator).

Computerized System and Data Integrity QA Manager at Idorsia Pharmaceuticals Ltd

Ensure compliance of computerized systems: determine regulations applicable and need for validation; Apply advanced knowledge to address complex issues; Review/create validation documents; Support efficient integration of Data Integrity in CSV activities; CSV and data integrity training for key stakeholders; Support CSV QA Team Leader in the preparation of Validation and Data Integrity Plan; Primary contact between the computerized system project team and Pharmaceutical Development Department; Lead Auditor to ensure compliance along the lifecycle; Represent Idorsia during internal/external audits and coordinate audits; Follow-up on Corrective/Preventive Actions and vendor assessments; Data Integrity governance responsibilities.

Quality Project Manager consultant at Idorsia Pharmaceuticals Ltd

Quality Training update following the implementation of a new Veeva interface; Decommissioning of Master Control system; Quality Documents migration from Master Control to Veeva including migration protocols redaction; Automatic migrations management and coordination; Business test management and execution.

Quality Project Manager consultant at Janssen (Johnson & Johnson)

Study data migration from legacy system to new one; Migration protocols redaction; Automatic migrations management and coordination; Business test management and execution; Quality Documents and Quality Event management System/Software upgrade; Changes coordination; Qualification documentation (VP, URS, IQ, OQ, PQ, RTM and VR); Access management; Publication of new version documents; Migration of documents from Master Control and iTRACK to Veeva; Decommission Master Control.

Equipment Qualification Project Manager consultant at Merck Serono / Philips Morris

Production bioreactor projects (controlled rooms) and peripherals upgrades / qualification documentation (URS, IQ et OQ) and testing; Non-conformity/deviation and CAPA management.

Production Engineer (apprentice) at Gélatines Weishardt

Comparison analysis and technical studies and suggested technical solutions for process modification and optimization; Economic evaluation, organizational and QHSE impact assessments; Production issues management; Update of production quality documentation.