Johnson & Johnson
NL - Data Integrity Subject Matter Expert
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
DI SME job description:
The Data Integrity Subject Matter Expert (SME) works within the Site Data Integrity Team and report directly to the Senior Site Data Integrity Lead. The Data Integrity SME provides expert guidance and advice to ensure that the Data Integrity Project for manufacturing / production systems meets the expected goals. The Data Integrity SME analyzes gap assessments and proposes solutions by technical or procedural means, organizes site resources for remediation, and coordinates and supports the Business and Technical System Owners in remediating systems gaps.
- Performs DI assessment, analyses data integrity gaps and participates in data integrity remediation.
- Guides Business and Technical System Owners in current expectation of Data Integrity.
- Understands both technical and procedural requirements of Data Integrity applied to manufacturing systems in a GxP PLC / HMI / SCADA / MES environment.
- Understands the connected production processes to identify the most efficient action to be taken at any step of the data flow.
- Understands security administration, user access management and system audit trail reviews at the procedural level for a GxP environment.
- Manages work according to the agreed planning and working schedule, being capable to coordinate with the team and also to close tasks individually.
- Writes and revises system administration SOPs, Work Instructions, URS, etc? for satisfying regulatory and enterprise data integrity requirements.
- Supports QA in managing quality actions, investigations, deviations and CAPAs related to Data Integrity.
- Collaborates with the global Community of Practice to share best practices in DI and align with all other Sites involved.
Magnitude & complexity:
The focus of the function is to execute remediation actions that ensure that the core computerized manufacturing systems at JBV meet the current requirements of Data Integrity.
The complexity lies in the fact that position operates in a multi-functional (and, exceptionally, in a multi-site) environment where continuous improvement is required. The position requires a strong analytical and independent thinking and decision making to find structural, regulatory, and business-wise sound solutions.
Requirements & Minimum experience:
- Extensive, in depth knowledge of regulatory requirements for Data Integrity for pharmaceutical manufacturing computerized systems and recent developments in this expertise area is a requirement.
- Minimum of Bachelor?s Degree or equivalent in computer science, engineering or equivalent.
- Minimum 4 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 strongly preferred.
- Experience in a complex, multinational work environment/company is preferred.
- Pharma experience would be a big plus
- Working experience in a complex environment.
- Gap identification by using an assessment.
- Dutch a nice to have, English must have.
- You will work onsite 3 days per week.
- This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner Yacht in the Netherlands. They can offer you a employment contract or a freelance contract (ZZP).