A well-known international pharmaceutical company with sites around the globe is looking to hire a QA GMP Deviation Consultant to be based in Italy. The company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology.
- 3-month contract based in Italy to assist with an FDA remediation project to resolve Deviations in a sterile manufacturing plant.
- Responsible for investigating manufacturing deviations and writing investigation reports
- Route Cause Analysis
- Plan corrective actions
- 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 company Quality Senior Management;
- Interact with site and above site personnel during the course of the investigation and through its completion and approval.
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 Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.