Our client operates a Grade A sterile facility in Southern Italy. They are currently searching for Deviation Investigators to join them on a 3 month rolling basis. The project is likely to go on long term but will be offered on a 3 month rolling basis.
Job Role and Responsibilities:
- Assist in investigating deviations and writing investigation reports;
- Formulate investigation plan, gather relevant documentation (e.g, SOPs, batch production records, equipment logbooks, test records, validation reports, etc.) interview relevant personnel (e.g. production, maintenance, tech. services, etc.), develop root cause analysis, determine scope/impact, and develop corrective/preventive actions;
- Assist in determining the actions and closure of change controls and the corrective and preventive action (CAPA);
- In furtherance of the evaluation and verification of deviation investigation, change control and CAPA activities, provide on-site expertise at the facility to serve as a working consultant to Quality Senior Management;
- Interact with site and above site personnel during the course of the investigation and through its completion and approval.
The successful candidate must have previous experience of working in a Grade A sterile manufacturing environment. You will have a proven track record in investigating deviations under sterile manufacturing conditions.
This is an exciting opportunity to join a large multinational in a diverse role that will offer great exposure to highly sought after project experience. The role is set in a wonderful location and brings a great lifestyle. The project offers 50 hours per week and a 4 week rotation.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Owen Bach on +44 203 8261 330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
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