Freelance CSV Specialist

pbThis position can be filled by freelance or employee consultancy via a payroll partner. /b /p pFor a customer in Limburg, we are searching for a CSV Specialist to ensure that all IT systems that have an impact on GMP are maintained in a validated state. /p h3Responsibilities /h3 ul liMaintain an overview of all IT systems and the extent to which they have undergone CSV; manage and monitor their validation status to ensure that all software and hardware modifications, changes, and updates are also subject to CSV. /li liKeep the Computerized System Validation Master Plan and all validation-related procedures up to date. /li liMaintain an up-to-date overview of GMP-critical computerized systems and their validation status. /li liPrepare specific validation documents for GMP computerized systems, such as risk assessments, regulatory assessments, test protocols, and reports. /li liSet up, implement, and ensure the continued effectiveness of validation studies, or coordinate these activities, in consultation with employees from the IT department and potentially also Operations, Supply Chain, Technical Services, QA, and Engineering. /li liDocument, or ensure the documentation of, all validation activities and validation results, particularly those relating to CSV. /li liContribute to the improvement and optimization of personnel, processes, systems, and implemented procedures. /li liAssess the validation requirements resulting from proposed changes to systems, processes, installations, or equipment, particularly changes relating to CSV. /li liInitiate and carry out the validation of systems, processes, installations, and equipment in a timely manner. /li liEnsure that validation activities are performed to an appropriate standard and comply with applicable international legislation and regulations concerning validation and GMP (GAMP 5 / Annex 11 / Part 11 and data integrity). /li liCollaborate across the shared CSV systems, such as ERP, Electronic Batch Record, Asset Management Systems, Artwork Management, and Control Systems. /li liAct as the Subject Matter Expert (SME) for CSV during external audits. /li /ul h3Profile /h3 ul liPreferably a Master's or Bachelor's degree in IT, with at least HBO-level professional and intellectual ability. /li liSeveral years of experience within a pharmaceutical manufacturing environment is an advantage. /li liExperience in setting up and managing CSV or other validation studies is an advantage. /li liFamiliar with GMP guidelines, pharmaceutical guidelines, hygiene requirements, etc. /li liKnowledge of GAMP 5. /li liExperience with quality systems, procedures, training, etc. /li /ul pSENIORITY: Medior/Senior /p pSTART DATE: October/November (ASAP) /p pDURATION: 12 Months /p pEXTENSION: Yes /p pCONTRACT: Freelance or Consultant (payroll) /p pLOCATION: Limburg /p pONSITE POLICY: Flexible
- TBD /p pHOURS PER WEEK: 40 /p pINTERVIEW PROCESS: 1-2 stages /p