Quality Manager

My client, a leading Pharmaceuticals giant, is looking to recruit a Quality Manager, based in Woking.

typical duties will include;

Advise the Project Managers team on Qualification best practices
Support and drive Infrastructure qualification and validation activities
Advise project teams on qualification and validation approach for infrastructure components/validation of applications
Liaise with IT Compliance and or Quality Assurance to agree qualification approach for project components/validation of applications
Review and approve qualification and validation life cycle documentation
Qualification plans
Requirements specification
Regulatory Impact Assessment
IQOQ Protocols
IQOQ Records
Traceability Matrix
Qualification Reports
Test Deviation Reports
Procedural Deviations
Ensure documents filing both hard copies and electronic equivalents

Experience required

At least 5 years experience in GxP and Computer System Validation in Pharmaceutical/Life Sciences and or Medical Device companies
Chartered Quality Professional certified by the Chartered Quality Institute (CQI)
PQMS Lead Auditor - certified by the International Register of Certificated Auditors (IRCA) - which is an off shoot of the CQI
Certified Pharmaceutical Industry Professional (CPIP) certified by the International Society for Pharmaceutical Engineering (ISPE)

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