Computer Systems Validation (CSV) Specialist

Recruiter
Barrington James Ltd
Location
West Sussex
Posted
02 Dec 2017
Closes
11 Jan 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
A rapidly growing Medical Device company in the South East of England are searching for a Computer System Validation Specialist to join their expanding team. My client specialises in the manufacture and design of medical devices used frequently in optometry, as well as associated surgical instruments.

They are looking for an experienced CSV specialist with excellent interpersonal and communication skills. The company provides a unique, collaborative environment in which there are many opportunities for progression, and are willing to provide appropriate training to the right candidate.

Responsibilities:

- Determine the validation requirements for the company's computerised systems, following a risk-based approach.
- Expand and maintain current regulatory requirement knowledge and industry best practice.
- Help develop colleagues' validation knowledge, allowing them to effectively fulfil their roles and responsibilities.
- Manage validation activities required leading up to the approval of documents such as validation plans and protocols.
- Investigate and document deviations from protocol as well as non-conformance incidents.
- Present the company's compliance status through regulatory inspections and audits.

Requirements:

- A degree in Computer Science, Engineering, or a related subject.
- At least 2 years' experience in a CSV position or equivalent.
- Experience of working in a Medical Device, Pharmaceutical or a similar regulated industry.
- Awareness of IT infrastructure and how ERP and IT systems are used by a business.
- An understanding of GAMP5 as well as Risk-Based Validation.

Benefits:

- Extensive training programme offered.
- The ability to travel for the company, as required.
- A competitive salary package.
- The opportunity to work in a company whose core values include integrity, respect, and ambition.

This is a fantastic opportunity for a CSV specialist to expand their knowledge and portfolio, whilst being a part of a driven, positive and supportive team.

If this position is of interest to you then find out more by sending your CV to *************************** or applying directly to this advert.

LinkedIn: ********************************-heater-3a45b4151/

Telephone: ******************