Data Integrity Subject Matter Expert
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a Data Integrity Subject Matter Expert.
As Subject Matter Expert, you work within the site Data Integrity Team, specifically focusing on manufacturing and analytical systems linked to Covid-19 Vaccine production. You will perform and analyse data integrity gap assessments and propose remediations (technical, procedural, trainings), coordinate activities and stakeholders to lead to full gap remediation. You offer guidance and support to the business to improve GMP processes related to DI topics such as Security / User Access Management, Audit Trail Review, Backup & Archival.
- Understand both technical and procedural requirements of Data Integrity in manufacturing and analytical environment
- Collaborate with Business System Owners, Technical System Owners, QA, and Training to identify the most efficient action to be taken for any system and at any step of the data flow
- Analyse data integrity gaps and leads activities toward remediation
- Improve the procedural framework related to DI topics
- Guide Business System Owners and Technical System Owners in meeting current and prepare for future expectation of Data Integrity
- Manage work according to a schedule
The focus of the function is to coordinate stakeholders and execute remediation actions to ensure that Processes and Data generated by Computerized Systems at JBV meet the current requirements of Data Integrity throughout the Data and System life cycles.
The complexity lies in the fact that the position operates in a complex, multi-functional, and sometimes multi-site environment, where continuous improvement of the Data and Computerized Systems processes are required.
Who we're looking for
For this role, we are looking for a candidate with in-depth, up-to-date knowledge of computerized systems, GMP and specifically Data Integrity practices and recent developments in this expertise area. You have at least a Bachelor’s degree and minimum 6 years of work experience in GxP pharmaceutical environment. Previous work experience within Quality Assurance Departments or in the field of computerized systems Quality / validation is an advantage. You are independant, have a critical way of thinking and good decision making skills to find sound solutions from a structural, regulatory, and business perspective.
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Project for at least 12 months, extention possible. |
Available to be on site in Leiden min. 3 days/per week
Salary: 48000 - 68000
Days of leave: 36
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.