Computer Systems Validation (CSV) Specialist
Position: CSV Specialist
Location: Houghton Regis
Salary: £45000 - £55000
Arjo is a successful medical device manufacturer and distributor addressing Patient and Post-Acute Care (PPAC) needs in several countries. We have invested significantly in Computerized Quality Systems and we are recruiting for a Computer Systems Validation Specialist who will be a key player in this IT-CSV and QSR-CSV set up, interfacing with a wide variety of key stakeholders inside and outside the organization.
In this position you will ensure a global framework for Computerized Systems Validation (CSV) of IT systems handling quality data (GxP data) in compliance with regulatory requirements for medical devices, electronic records and electronic signatures.
This is a real opportunity for an individual looking for a varied role where you have the possibility to contribute to developing the quality and regulatory compliant organization.
- Coordinate across IT function to validate systems as per CSV framework
- Create and maintain CSV Procedures and Quality Policies and Guidelines
- Create and Review Computer System Validation Documents and SDLC Documentation
- Contribute to Change Control Process, Impact Analysis and Risk Assessments
- Address and follow-up on deviations occurred during execution of qualification/validation activities
- Conduct Periodic Reviews
- Ensure Systems are maintained in a validated state via change control
- Train Stakeholders in Computer Systems Validation Framework including preparation of training material
- Train Stakeholders in Software Development Life Cycle including preparation of training material
- Perform internal audits of CSV packages.
- Participate in internal and external Q&E MS audits and external vendor audits.
- Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP), MAP, etc.
ESSENTIAL SKILLS / EXPERIENCE:
- Bachelor’s Degree in Computer Science or IT Engineering or equivalent
- Past experience creating and reviewing documentation for Quality Systems or appropriate qualification in Business Systems Analysis preferred
- Possess an understanding of Computerized System Validation and Software Development Life Cycle
- Experience in developing and working with Quality IT systems and CAPA Systems.
- Experience with project management and stakeholder management
- Experience in delivering training
- Knowledge of applicable regulations and standards, e.g. ISO 9001, ISO 13485, FDAs QSR and Part 11 and Part 820 or willingness to develop knowledge
- Sound Knowledge of GAMP’s: (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 Systems).
- Knowledge of SW development and testing processes.
- Experience in using Microsoft Word, Excel, PowerPoint, Visio and SharePoint
- The role requires international travel, approximately around 10%
- You will be reporting to the IT Quality and Compliance Manager
Please be aware that by applying for this role, you are giving Arjo permission to store your information.