Csv Consultant - Bristol, United Kingdom - VQ Life Sciences
Description
CSV Consultant
VQ Life Sciences are recruiting for a
CSV Consultant, Permanent or Contract. This is a
hybrid remote/ client facing position ensuring that our client requirements are translated into effective quality and compliance services and solutions that are delivered in the most optimum way.
ROLE
- To effectively plan Computerised System Validation (CSV) and Data Integrity (DI) programmes / projects in accordance with client requirements, regulatory requirements, and industry best practices.
- To lead programmes / projects / work packages in accordance with agreed plans to the satisfaction of customers.
- To support the development of skills and competencies within the organisation.
- To establish effective client relationships to generate new business opportunities across the business service areas.
KEY DELIVERABLES
- To be a team player, providing support where required to colleagues.
- Clear communication skills to provide direction, communicate expectations and articulate opinions and solutions.
- To be able to create clear and concise documents.
- To establish excellent customer relationships to secure business continuity.
KNOWLEDGE AND EXPERIENCE
Experience in all aspects of CSV projects including understanding or experience of:
- Supplier Assessment
- Riskbased Validation Planning and Reporting
- Requirements Management, Design Verification and Traceability
- Lifecycle Risk Management
- All aspects of testing including test phases Installation Verification, SIT / OV, UAT / PQ.
- Experience in the create, execution, review, approval of test cases and associated test defect management, Test Summary Reporting
- Data Migration Planning and Verification
- Operational Controls e.g., Change control, configuration management, incident management, deviation management, CAPA, etc
- Periodic Review
Experience of Data Integrity Programmes including:
- Identification of the data integrity issues and threats
- Planning and execution of DI programmes addressing all aspects of culture, behaviours, technologies, and processes.
- Prioritising programmes and remediation based on risk (e.g., evidence of DI incidents, product risks, etc)
- Use of a range of DI tools including GEMBA, maturity assessment, gap analysis, data analytics
Experience of a range of regulated organisations including:
- Global and small organisations
- Pharmaceuticals, Biotechnology, Medical Devices
- Global regulations including all regulatory domains GLP, GCP, GMP, GDP, GPvP
Other regulatory experience:
- Experience of other regulated, legal requirements would be beneficial including Data Privacy, Sarbanes Oxley would be beneficial
Manufacturing systems (e.g., PLCs, SCADA, Data Management, Utilities, etc)
- Laboratory systems (e.g., LIMS, analytical instruments, HPLC, GC, Titration, etc)
- Supply Chain (e.g., Warehousing, Batch release, distribution, ERP, transport management, etc)
- Pharmacovigilance (e.g., intake tools, adverse event reporting, etc)
- Experience of IT Infrastructure Verification processes including leveraging IT Quality practices, tools, and automation to ensure efficient and effective control.
INDUSTRY
- Understanding of global regulatory requirements / guidance pertaining to computerised system validation e.g., US FDA 21 CFR Part 11; Electronic Records and Electronic Signatures, European Annex 11 Computerised Systems, PIC/S
- Understanding of global regulatory requirements / guidance relating to Data Integrity, MHRA, US FDA, WHO
- Understanding of industry good practices e.g., ISPE GAMP Guidelines and Good Practice Guides
Reference:
DO385-2
Job Features:
- Job Category
- CSV
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