Company: Hydrogen Group
Closing Date: 15 Dec 16
Salary (£): Negotiable
This is an opportunity to work as a Quality Assurance Officer (QAO) for Kinesis Pharma which is an international contract research organization (CRO) with headquarters in Breda Netherlands. Kinesis leverages the expertise and experience of its highly-skilled, multi-disciplinary workforce to accelerate development of medicinal products.
* To conduct study, process, system and facility based audits according to the QA audit program, QA manual and relevant (GxP) guidelines;
* To report promptly audits to the responsible persons e.g. Study Director/Principal Investigator/Consultant and General Manager;
* To coordinate with the Quality Assurance Manager (QAM) the planning of study, process, system and/or facility based audits;
* To maintain the timelines of the audit responses of the responsible person e.g. Study Director/Principal Investigator/Consultant;
* To provide audit reports to Study Director, Leading QA, Test Facility Management in case of multi-site studies;
* To attend and/or initiate QA meetings with respect to audit findings;
* To maintain the master schedule;
* To write, update or review SOPs and manuals in accordance with the current procedures and GxP Guidelines;
* To initiate, review, assess and evaluate CAPAs;
* To initiate, guide or monitor Root Cause Analyses and Risk Assessments;
* To perform Gap Analyses;
* Provide GxP training;
* Provide GxP support and advice in changes and projects on GxP-aspects.
30 Eastcheap London
|Tel:||+44 (0) 207 002 0000|
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