For a leading pharmaceutical & biotech company I am looking for an enthusiastic CSV consultant to assure that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for national computerized systems.
- Review and approve CSV documents such as SOPs, user requirements, impact/risks analysis’s, Validation Plans, tests, etc…) to maintain compliance to regulations, guidelines, J&J and Janssen policies and standards. ·
- Be part of engineering teams and interact with other groups for the introduction of new systems and processes. To give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects.
- Be a member of cross-functional teams to realize cross-departmental objectives.
- Address and follow-up of deviations occurred during execution of qualification/validation activities. Evaluate the incidents related to CS and propose corrective actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if this is the case.
- Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP,…), MAP, etc.
- MHRA GFI on Data Integrity and related GMP Guidelines and Preambles.
- Knowledge of GAMP’s: generic and specific (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP System)
- Knowledge of SW development and testing processes.
- MHRA GFI on Data Integrity and related GMP Guidelines and Preambles. · Knowledge of GAMP’s
- Knowledge of Quality auditing
- Knowledge of Software quality metrics
- Capacity to ‘translate’ technical information into information that can be understood at every level of the organization.
- Being able to correctly estimate the urgency, criticality and impact of decisions related to the function.
- Ability to multi-task and work on a variety of projects at one time.
- Ability to work independently and work in cross-functional team environment.
- University degree or similar
- Fluent in English (written and spoken)
- Fluent in Dutch
- Quality Management System
- Process control and IT systems used within pharmaceutical or chemical manufacturing environment: MES, ERP, PLCs, warehouse management systems, laboratory control systems, environmental monitoring systems, historian…
- Problem reports change request systems. (f.e. Trackwise)
- Document Management systems (f.e. Docspace/TruVault)
- Training Systems (f.e. ComplianceWire)
- SAP systems
- Test tools (f.e. HP ALM)
40 hours a week
12 months with high chance of extension / starting January 2022
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information, please contact Oliver Holding Fay on +31 (0)20 20 44 502 or firstname.lastname@example.org