Computer Systems Validation CSV Coordinator
Our client is a niche pharmaceutical company with R&D and manufacturing laboratories based in Hertfordshire. They are seeking a validation professional with a background in CSV to join their busy team.
Work as part of a team on CSV Projects across the group of companies.
Ensure compliance with internal and external regulatory requirements throughout the system development lifecycle.
Perform the role of Validation Team Leader as appropriate on CSV Projects.
Assist in the preparation, review, approval and issue of Computer System Validation Documentation.
Assist in the maintenance of the CSV Master Plan and System Register.
Maintenance of traceability / document matrices.
Maintain the library of validation documents and ensure they are available for inspection whenever required.
A good understanding of CSV and the principles of GxP (GMP, GLP etc).
Knowledge of software testing and installation.
Previous experience in use of, and validation experience of, commonly used systems in Pharmaceutical environments i.e. LIMS, Chromatography Data Systems, Laboratory Analytical Systems, manufacturing systems, eDMS, ERP etc.
High level of skill in use of common MS Office applications (Word, Excel etc.).
Well organised and able to prioritise own workload around a range of deadlines from different sources.
Strong communication, interpersonal and people skills.
High attention to detail.
- Computer System Validation
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