Equipment & Data Integrity Expert - Life Science - M/F/X

Akkodis

  • Wallonie
  • CDI
  • Temps-plein
  • Il y a 11 jours
About the Company:AKKODIS is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. As part of the development of the activities at one of our clients in the pharma industry, we are looking for our new Consultant.About the Role:As an Equipment & Data Integrity Consultant, you will be responsible for:
  • Overseeing all aspects of digitalization and data integrity for QC and In-Process Control laboratories within the Manufacturing Engineering & HSE department, including operational use of laboratory equipment, new equipment projects, and electronic transformation projects of laboratory processes.
  • Working with a dynamic and motivated team of experts, interacting with Quality Control, IT, Qualification, and Quality Assurance departments.
Key responsibilities:
  • Participating 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.
  • Performing risk assessments related to data integrity (DIRA) and providing recommendations to resolve and mitigate potential vulnerabilities.
  • Ensuring the security of raw data by proposing appropriate backup measures.
  • Creating system administration documents, defining security levels, and specifying roles/functions to be implemented.
  • Defining the access management process.
  • Executing, in partnership with colleagues, the “annual review” program of computerized equipment in the QC laboratories.
  • Managing incidents related to software (including Empower and LDMA - Laboratory Data Management and Archival) and laboratory equipment, addressing data backup issues and system access problems, and acting as first-line support.
Preferred Skills:Knowledge of Waters Empower and SDMS software.
Experience with compliance audit periods, FDA, etc.Qualifications:
  • Demonstrated experience working in a quality control laboratory and knowledge of various computerized analytical equipment and their configuration (security, access control, data protection).
  • Knowledge and understanding of compliance and data integrity requirements in the analytical laboratory field, particularly in a Bio-Pharma context.
  • A continuous improvement mindset and the ability to propose solutions to enhance departmental efficiency.
  • Experience in data integrity risk assessment.
  • Knowledge of data security measures for equipment (Active Directory, Windows security groups).
  • Flexibility in managing priorities.
  • Fluency in French and English.

Akkodis