Role: QA Specialist
Location: North West England
Contract Length: 6 months (possibility to extend)
Rate: £38 - 43 per hour (dependent on experience)
The role will be to provide QA support throughout the validation lifecycle in particular with respect to the introduction of new equipment/capital projects/facility modifications on site (though may include legacy equipment as necessary).
The role will include (but not necessarily be limited to) the following aspects of validation:
ØReview of User Requirement Specifications to ensure that they have been generated in accordance with regulatory guidance and internal procedures.
They will also ensure that any quality critical requirements for the system have been correctly detailed in the URS.
ØParticipation in design reviews to ensure quality critical issues are addressed adequately and review and approval of the design qualification, system impact assessments, GAMP assessments performed.
ØParticipation in and approval of quality risk assessments associated with the capital projects.
Ensuring any risk mitigation actions are followed up by the Risk Management Leader.
ØSupport and guidance to ensure that all validation protocols meet client requirements, current standards and industry practices.
Ensure that all data relating to a validation exercise (including data for equipment/instrument calibration, planned preventative maintenance, exceptions, testing results) are collated correctly and reviewed by the system user / validation.
Ensure validation reports reflect the true finding of the validation exercise and that significant issues are communicated to the QA Team Leader in an effective manner.
ØReview and approval of revalidation assessments, ensuring that they have been completed in line with internal procedures and that all factors which may have an impact on the validated status of the system have been adequately assessed.
If you feel like you have the relevant skills and experience then please apply by following the relevant links or by contacting Georgie Dixon at LEAP29 (01625 537 555 ext:1014)
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