Data Integrity SME
You will work within the site Data Integrity project for manufacturing / production systems. Analyses data integrity gap assessments and proposes solutions, organises site resources for remediation and remediates systems gaps. Offer guidance regarding data integrity gap analysis and remediation actions to the DI Remediation Project Lead, Business and Technical System Owners. The focus of the function is to execute remediation actions that ensure that the core Computerized Quality Systems meet the current requirements of Data Integrity.
The complexity lies also in the fact that position operates in a complex, multi-functional, and sometimes multi-site environment, where continuous improvement of the core Computerized Quality Systems is required. The position requires a strong analytical and independent thinking and decision making to find structural, regulatory, and business wise sound solutions.
Extensive, in depth up-to-date knowledge of manufacturing computerized quality systems and recent developments in this expertise area is a requirement.
- 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 in a PLC / HMI / SCADA / MES environment
- Understands security administration at the procedural level for a GxP environment
- Manages work according to a schedule
- Manages quality actions in Trackwise
- Writes and revises system administration SOP's etc… for data integrity requirements Magnitude & complexity
- Minimum of Bachelor degree or equivalent in computer science or equivalent; supplemented with additional training or experience during work life.
- Pharmaceutical or related industry work experience for 4-6 years, of which a substantial part in Computerized Systems and related functions.
- Experience in a complex, multinational work environment/company.
- Project management skills and interpersonal skills, engaged in contact with personnel at all levels within the organization.
- Written and oral communication skills in English. Dutch is preferable.
- Self-starter, planning skills, and ability to prioritize multiple commitments.
- Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable.
- Pro Active, works independently, takes actions in the absence of specific instruction
- Excellent communication and advisory skills, result oriented.
For more information, please contact Robert Bots on : +3120 530 5888 or mail your resume, with a brief motivation to r.bots[@]progressiverecruitment.com