Description
My client a Charity based in London are currently searching for a Validation Engineer who has experience of Computer Systems Validation.The ideal candidate will be reporting to the IT Services Manager and will be responsible for validating the existing systems they have on site for a MHRA audit they have coming up.
Responsibilities:
- Delivers Computerised System Validation (CSV) compliant services to internal and external parties that have Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP) guidelines to adhere to, ensuring that CRUK remains compliant with the guidelines.
- Provides Subject Matter Expertise for CSV within the charity. Share specialist knowledge and expertise both within the department and the wider charity through the production of specialist training materials and the delivery of training sessions.
- Provides CSV Subject Matter Expertise to infrastructure and application teams and advises all teams on the requirements of GCP, GMP and CSV.
- Ensures that successfully passes any Medicines and Healthcare products Regulatory Agency (MHRA) inspections.
- Investigates incidents and reviews requests for Change that impact CSV.
- Performs CSV activities and risk assessments, including architecture reviews.
- Assists technical architects in the design and delivery of new GxP (GCP/GMP) services.
- Participates in drafting and maintaining SOPS; IQs, OQs, PQs and other documentation relating to the validated systems.
- Acts as the primary ITS point of contact for all internal and external audits and inspections.
- Manages and reports on MHRA audit actions across ITS.
- Manages and maintains the life cycle of the ITS Document Management Process.
- Attends and participates at Service/Performance Review Boards where appropriate.
- Works with the ITS Service Assurance Manager, key stakeholders and the IT Process Improvement Manager to continually improve the ITS Document Management and CSV processes.
- Represents Document and CSV Management at Process Governance meetings.
- Manages supporting tools including: new requirements, end user training and support.
- Develops and maintain technical expertise and knowledge of industry best practice.
This is an excellent opportunity for an immediate start. If you are interested in this opportunity please contact Reshma Patel on or emailimmediately.