Our client, a leading service provider for the pharmaceutical industry, is looking to hire Consultant Expert in Validation to join their team in Paris, France. This role is on a 6 month contract.
Job Role and Responsibilities:
- Evaluate qualification/validation documentation for computerised and automated systems
- Guarantee the maintenance of the validated status of computerised and automated systems (Change Control, review, validation)
- Ensure compliance with the applicable SI / SA procedures/instructions
- Identify deviations from the client's standards, international regulations and Pharmacopoeias.
- Write procedures and instructions related to computerised and automated systems
- Act as the QA representative for the assessment of Change Controls, deviations and CAPAs associated with the SI / SA activity
- Write the master plan for the validation of computerised/automated systems and the associated annual reports.
- Implement performance indicators related to the SI / SA activity
- QA support during audits and inspection
Skills and Experience:
- 10 years minimum in quality assurance and validation of computerised and automated systems
- Knowledge of SAP and Empower systems is strongly desired
- Excellent relationship skills (exchanges with production, engineering, EIA, external service providers ...)
- Fluent in English
- Intermediate French is expected as a minimum, Fluent French is desirable but not essential
Applications MUST be in English
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 Will Hitchcock on +44 203 0789 554 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.