Cleaning and E&L Validation

AKKODIS Belgium is looking for an experienced person in a pharmaceutical environment in the field of validation.

What are your responsibilities?

·       Evolve at a global level for the company and in collaboration with different business units.

·       Contribute to the creation of the internal strategies for Cleaning and Leachables & Extractables (E&L) validation aimed at anticipating the expectations of new regulations.

·       Be able to implement training comprehensive package for both expertises.

·       Find information from a variety of sources to suggest innovative approach.

·       Set up and ensure a standardized way of working on cleaning and E&L validation expertises.

·       Assist during internal audits and inspections by authorities.

·       Provide site support related to questions and issues.

·       Participate to the Quality Escalation process.

·       Supervise the establishment and regular updates of cleaning validation libraries.

·       Lead central program of E&L studies outsourced to external labs.

·       Monitoring & reporting on benefits about the application of the cleaning and E&L validation approaches.

·       Participate and develop SME network for cleaning and E&L and associated events.

·       Be comfortable with issue guidance, position paper, expert opinion documents written in plain English.

E2936205829E43B0B8AD6D18B4BDB502@ts.com