Paris2015 - maintenantSubject Matter Expert for Equipments Re-Qualification , including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems.
Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
Author and when required review qualification and validation documentation, including risk assessments, specification documentation, validation plans, protocols, reports, traceability matrix and summary reports.
Conduct investigations into qualification failures and develop and implement remediation plan.
Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems.
Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes.
Participate to the development and maintenance of the local site procedures
Participate to risk assessments and risk management teams
Review change controls to evaluate impact on qualified systems and validated processes
Develop and justify the validation approach based on risk and a scientific rational
Co-ordinate qualification and validation execution activities, including external vendors and internal departments
Establish and maintain effective relationships with internal team, customers and suppliers
Celgene
- Validation intern
Paris2015 - 2015Develop and maintain local site procedure
Execute equipment qualifications and process validation
Coordinate qualification and validation execution activities, including external vendors and internal departments
Develop and justify the validation approach based on risk and scientific rational
Conduct investigations into qualification failures
Develop and implement remediation plan
Ensure that the equipments, systems and processes are qualified, validated and maintained in compliance
