Validation Specialist

Ref: HM7124 Salary: £Flex DOE Contract Type: Temporary Location: Folkestone

A new instruction for a Validation Specialist with an established manufacturing client in the area.

This is an exciting opportunity to join the Quality Team on a long term temporary basis for initially 6 months, with the possibility of an extension, and reports to the Validation Lead.

1. Work with colleagues in the Validation Team on Quality Management system improvements to existing processes.
2. Develop and execute process system validations.
3. Provide manufacturing quality input to Product Development groups.
4. Comply with and promote compliance with the relevant GMP and hygiene procedures and standards.

1. University degree in a related field of Science or Engineering.
2. A professional with technical experience and a demonstrated track record.

1. Broad experience of all key areas of Quality Assurance.
2. Working knowledge of the MDD, MDR, 21CFR 820, ISO 13485, ISO 14971, ISO 22716.
3. Experience of data analysis, data trending and preparing KPI's.
4. Excellent communication skills for complex ideas across a range of groups.
5. Team player with attention to detail and excellent interpersonal skills.

1. Working with Validation Specialists to manage the operational validation activities within the plant.
2. Conduct validation reviews - initial and annual.
3. Conduct regular site surveys to ensure that the Site Validation Master Plan is kept up to date.
4. Provide support to the Validation Specialist to ensure that Root Cause/FMEA are followed and maintained.
5. Help to maintain a compliant validation strategy for the plant.
6. Provide support for operations on technical issues, project and planned validation activity timelines.
7. Work with Validation Specialist to coordinate validation activities as required.

An excellent rate of pay is available depending on your level of experience.

Monday to Friday, 37 hours per week, Site based.

If you have the background and knowledge we are seeking, then your application is warmly invited.

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