Senior Validation Consultant (Csv/ Csa)
4 days ago
Valladolid
ph3What You'll Be Doing /h3 ul liLeading Computer System Validation (CSV) activities throughout the system lifecycle /li liDeveloping validation strategies and documentation in accordance with GAMP® 5 (2nd Edition) /li liSupporting implementation and validation of regulated IT systems including ERP, LIMS, MES, Veeva Vault, eQMS and Document Management Systems /li liPerforming GxP risk assessments and supplier assessments /li liSupporting audit and inspection readiness activities /li liCollaborating with business, IT, quality and external vendors across international project teams /li liAdvising clients on best practices for Computer System Validation and Computer System Assurance (CSA) /li /ul h3What we’re looking for /h3 pMinimum 5 years of experience in Computer System Validation (CSV) within the pharmaceutical, biotechnology or medical device industry. /p pStrong understanding of GAMP® 5, EU Annex 11, 21 CFR Part 11 and GxP requirements. /p pExperience with one or more of the following technologies: SAP, Veeva Vault, LabWare or Labvantage LIMS, MES, TrackWise, Document Management Systems, ERP implementations. /p pExperience working in international project environments. /p pFluent English (required) and German (preferred). /p pExcellent communication and stakeholder management skills. /p ul liExperience with Computer System Assurance (CSA), Data Integrity or Digital Quality is highly desirable. /li /ul h3Why join Qualitice? /h3 pWork with some of the world's leading Life Sciences organisations. /p pFlexible remote‑first working model. /p ul liInternational projects across Germany, Switzerland and Europe. /li /ul pOpportunity to work alongside highly experienced consultants on complex global transformation programmes. /p pFlexible collaboration models (permanent employment or freelance). /p pJoin a fast‑growing specialist consultancy with an exclusive focus on Digital Quality Compliance. /p h3Compensation Benefits /h3 pCompetitive hourly rates or salary depending on experience and engagement model. /p /p #J-18808-Ljbffr