As a Laboratory Digitalization Partner, you will be responsible for all aspects of digitalization and data integrity of the QC and In Process Control laboratories of the Manufacturing Engineering & HSE department, be it for the operational use of laboratory equipment, new equipment projects, electronic transformation projects of laboratory processes.
You will join a dynamic and motivated team of four experts reporting to the Equipment and Data Integrity Manager, interacting with the Quality Control, IT, Qualification and Quality Assurance departments.
Your main tasks will be to :
- Participate, as a data integrity expert, in projects and validation of stand-alone computerised systems in collaboration with the Business Project Manager, the qualification/validation, metrology/maintenance, quality assurance and IT teams and ensure the timing of project deliverables
- Within the framework of new laboratory equipment installation projects:
- Execute the data integrity risk assessment (DIRA) and make recommendations to resolve any 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.
- Prepare and execute, in partnership with colleagues, the "annual review" programme of the computerised equipment of the QC laboratories of the Braine campus.
- Ensure the management of incidents concerning software (including Empower and LDMA - Laboratory Data Management and Archival-) and laboratory equipment, which concern data backup problems and system access problems. Acting as a first line of support.
- Work in partnership with the Analytical Data Management team to ensure alignment, proper integration and harmonisation of data structuring and appropriate taxonomy when defining and implementing digitisation
Interested? For this position, you must have the following training, experience and skills:
- Experience of working in a quality control laboratory and knowledge of the different computerised analytical equipment and their parameterisation and configuration (security, access control, data protection).
- Knowledge and understanding of compliance and data integrity aspects and requirements in the field of analytical laboratories in a Bio-Pharma context.
- Ability to give and receive feedback
- Work in a spirit of continuous improvement and spontaneously propose solutions in order to increase the efficiency of the department's processes on a daily basis
- Demonstrates flexibility in managing priorities
- Work with maximum autonomy
- Be proactive towards the client or colleagues in order to solve any problem constructively and effectively.
- Practical experience in the context of audit and compliance inspection is a plus.