Brabant Wallon – contracting
Equipment & Data Integrity Associate
Description de la fonction
- Participate as a data integrity expert in projects and validation of stand-alone computerized systems in collaboration with the Business project manager, qualification/validation teams, metrology/maintenance, quality assurance, and IT.
- In the context of new laboratory equipment installation projects:
- Perform the Data Integrity Risk Assessment (DIRA) and make recommendations for resolving and mitigating potential vulnerabilities.
- Ensure the security of raw data by proposing appropriate backup measures.
- Create the system administration document and define the security levels and types of roles/functions to be implemented.
- Define the access management process.
- Execute, in partnership with colleagues, the "annual review" program for the computerized equipment of the QC laboratories
- Manage incidents related to software (including Empower and LDMA - Laboratory Data Management and Archival) and laboratory equipment, addressing data backup issues and system access problems. Act as first-line support.
Profil
- Demonstrated experience working in a quality control laboratory and knowledge of various computerized analytical equipment, including their parameterization and configuration (security, access control, data protection).
- Knowledge and understanding of compliance and data integrity requirements in the context of analytical laboratories within the Bio-Pharma industry.
- Working with a continuous improvement mindset and proactively proposing solutions to enhance the department's process efficiency daily.
- Experience in data integrity risk assessment.
- Knowledge of data security methods for equipment (Active Directory, Windows security groups).
- Demonstrates flexibility in managing priorities.
- Fluent in French and English (business English for document writing and maintenance).
Considered a plus:
- Knowledge of Waters Empower and SDMS software.
- Experience during compliance audits, FDA, etc.
Offre
- Voiture d'entreprise
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
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