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Data Integrity Subject Matter Expert | Big Pharma | Leiden

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The company

Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands. For more than 25 years, Janssen Biologics has been a leader in the field of biomedicines. Through the dynamic science of biotechnology, they continue to seek innovative ways to treat cancer, infectious diseases, cardiovascular and metabolic diseases, and immune-mediated inflammatory disorders. Their work has revolutionized the science of immunology. They pioneered monoclonal antibody technology, a cutting-edge approach that launched a new generation of products to treat immune-related diseases. Janssen Biologics is a wholly owned subsidiary of Johnson & Johnson.

Role description

You work within the site Data Integrity project for manufacturing / production systems. You analyse data integrity gap assessments and propose solutions, organise site resources for remediation and remediate systems gaps. You offer guidance regarding data integrity gap analyses 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.

Responsibilities

• 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

Requirements

Minimum of Bachelor degree or equivalent in computer science or equivalent; supplemented with additional training or experience during work life. Work experience within the field of computerized systems quality / validation is preferred.
• 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.

Other information



Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.

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SIRE Life Sciences®

Listed by: SIRE Life Sciences®
Listed on: 12-02-2019
Country: The Netherlands
Region: Zuid-Holland
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Pharmaceutical
Specialisation: Quality

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