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French Speaking CSV Engineer
Eingestellt von Optimus Search
Gesuchte Skills: Engineer, Client, Cad
Projektbeschreibung
COMPUTER SYSTEMS VALIDATION ENGINEER
Location: Near Brussels
Salary: €500 per day
Contract: 12 months
My client is a global Pharmaceutical company who thanks to their recent expansion, are looking to bring on a talented CSV Engineer to join their team near Brussels, Belgium.
RESPONSIBILITIES INCLUDE:
- Ensuring business processes are designed to meet the requirements of relevant good practises (GxP)
- Support the RFP process, solution review and selection
- Validation activities supporting the implementation of a centralised Computer Aided Design (CAD)
- Validation activities supporting the rollout of the Enterprise Quality Management System (Master Control, SaaS)
- Validation activities supporting the implementation of a centralised Product Stewardship system
- Validation activities supporting the development and implementation of interfaces to/from other global systems (SAP, Data Warehouse, Ticketing System)
- Conducts Vendor Audits
- Regulatory considerations of Requirements, Systems, Processes and ensures Requirements are appropriately specified and testable
- Coordinates Business Criticality Risk Assessments
- Coordinate Supplier team through Risk Based compliance approach (Traceability Matrix and Risk Assessment)
- Develops Validation Plans and Test Protocols to define the approach to system verification
- Develops appropriate test scripts, review results, develop testing summary reports and release notes
- Must have extensive experience of Computer Systems Validation (to GAMP5) in the Pharmaceutical/Medical Device/Life Sciences industries
- Good understanding of US FDA (esp. 21 CFR Part 11) and UK MHRA Regulations, ISO Standards, GxP (GMP, GCP, GLP etc)
If this sounds like a role that suits your skill set and you would like to find out more, please get in touch with (see below) to kickstart the next stage of your career!
Location: Near Brussels
Salary: €500 per day
Contract: 12 months
My client is a global Pharmaceutical company who thanks to their recent expansion, are looking to bring on a talented CSV Engineer to join their team near Brussels, Belgium.
RESPONSIBILITIES INCLUDE:
- Ensuring business processes are designed to meet the requirements of relevant good practises (GxP)
- Support the RFP process, solution review and selection
- Validation activities supporting the implementation of a centralised Computer Aided Design (CAD)
- Validation activities supporting the rollout of the Enterprise Quality Management System (Master Control, SaaS)
- Validation activities supporting the implementation of a centralised Product Stewardship system
- Validation activities supporting the development and implementation of interfaces to/from other global systems (SAP, Data Warehouse, Ticketing System)
- Conducts Vendor Audits
- Regulatory considerations of Requirements, Systems, Processes and ensures Requirements are appropriately specified and testable
- Coordinates Business Criticality Risk Assessments
- Coordinate Supplier team through Risk Based compliance approach (Traceability Matrix and Risk Assessment)
- Develops Validation Plans and Test Protocols to define the approach to system verification
- Develops appropriate test scripts, review results, develop testing summary reports and release notes
- Must have extensive experience of Computer Systems Validation (to GAMP5) in the Pharmaceutical/Medical Device/Life Sciences industries
- Good understanding of US FDA (esp. 21 CFR Part 11) and UK MHRA Regulations, ISO Standards, GxP (GMP, GCP, GLP etc)
If this sounds like a role that suits your skill set and you would like to find out more, please get in touch with (see below) to kickstart the next stage of your career!
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik