Validation Specialist

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.

Will be to work with colleagues in the Validation Team on Quality Management system improvements to existing processes, to develop and execute process system validations and provides manufacturing quality into to Product Development groups.

The role carries responsibility to comply with and promote compliance with the relevant GMP and hygiene procedures and standards in the activities they undertake within the facilities.

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

• Broad experience of all key areas of Quality Assurance
• Working knowledge of the MDD, MDR, 21
  
  CFR 820, ISO 13485, ISO 14971, ISO 22716
• Experience of data analysis, data trending and preparing KPI’s
• Experience in data analysis and review (including trend analysis) for communication to management teams
• Excellent in communicating complex ideas across a range of groups
• Team player, attention to detail and excellent interpersonal skills

• Working with Validation Specialists to manage the operational validation activities within the plant

• Conduct regular site surveys to ensure that the Site Validation Master Plan is kept up to date
• Provide support to the Validation Specialist to ensure that Root Cause / FMEA are followed and maintained
• Help to maintain a compliant validation strategy for the plant
• Provide support for operations on technical issues, project and planned validation activity timelines
• Work with Validation Specialist to co-ordinate validation activities as required

An excellent rate of pay is available depending