CSV Engineer / Documentation Analyst - ISO Standards

Vadis People Service Ltd
London (Central)
11 Jan 2018
12 Feb 2018
Contract Type
Full Time
CSV Engineer / Documentation Analyst - ISO standards
Based: Central London
Rate: £300-£350 per day

Documentation Analyst / CSV Engineer with significant experience executing SOP’s to manufacturing / medical instruments / Pharama standards ( i.e. ISO90001, GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11 ) is required for our Client, a leader in the next generation of treatments in the war on cancer.

This opportunity is based in our Client’s London office with the possibility of balancing some of your time working from home. The role is being offered on a contract basis with the initial term likely to be 4/5 months.

The SOP’s have been agreed and our Client is offering a broad opportunity to execute on the SOPS ( Standard Operating Procedures )and this will involve qualification, validation and documentation of activities across the business and systems.

You will

- Provide the quality systems / documentation to confirm the SOP’s meet the regulatory requirements , in particular ISO 13485
- Support projects handling GxP critical computer systems
- Provide Computer system validation according to Software Development Lifecycle
- Provide User education / training, as required

To be considered for this long term contract we would expect the right applicant to have:

- Significant business / operational process experience (must be pharma, medical devices or manufacturing) with at least 12 months working in a similar role executing on SOP’s.
- Executing on national and international regulations and standards such as ISO90001, GAMP5, ISO 13485, ISO 62304, FDA QSR, 21 CFRPart 820, Part 11
- Experience in CSV system development life cycle.
- A background in implementing and documenting Quality Systems.

In return for your expertise you can expect a daily rate in the region of £300-£350 per day.
For further information please send your CV to Adam Davis at Vadis People Services Ltd. Vadis operates as both an Employment Agency and Employment Business.