QA Validation Coordinator Job in Lincolnshire ( South Humberside), Yorkshire UK
QA Validation Coordinator - Contract - Pharmaceuticals
Our client is a leading engineering and project management company.At present they are working on a pharmaceutical client site and require a QA Validation Coordinator on a contract basis at the facility based in the North, UK. The ideal candidate will have a background within pharmaceuticals and preferably Bulk API manufacturing processes. The successful candidate will have previous Validation experience and will be responsible to;
Support and Coordinate the Qualification Process for projects, including preparation of Qualification Project Plan (QPP), Systems Impact Assessment (SIA), Criticality Assessment (CA), GMP Review/Risk Assessment, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) Performance Qualification (PQ).
Prepare summary documents at the indicated stages of the project as required including the Qualification Report (QR) Provide the individual Project Managers with the necessary periodic reports which outline the status relating to adherence to milestones and schedules as it applies to qualification.
Monitor all Project Change Requests (PCR`s) for completion including possible deviations.
Follow up on actions arising from deviations, changes or pending items from qualification activities.
Follow up on action items from GMP Review/Risk Assessments
Preview all quality relevant documents from the various disciplines in the implementation of new plant and equipment for consistency with procedures, cGMP`s and Plant Change Controls. Review completed documents for accuracy and completeness.
Coordinate the changes (both Good Manufacturing Practise and Good Engineering Practise) to critical systems so that they are implemented, tested and documented in a controlled manner in compliance with plant procedures.