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Data Integrity Specialist (1 year project)

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

Data Integrity Specialist (1 year project)

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Zuid-Holland Netherlands.

The client is driven by the commitment to patients, the client brings innovative products, services and solutions to people throughout the world.

ROLE DESCRIPTION

You wil work within the site Data Integrity project for manufacturing / production systems. You will attend Data Integrity Gap Assessments as a DI SME, you analyse gap assessments, organise site resources for remediation and remediates systems gaps. Guide the data integrity regarding gap analysis and remediation actions to the Business and Technical System Owners.

RESPONSIBILITIES

• Organise meetings to assess the data integrity of production systems.
• Analyse results and participates in data integrity remediation
• Guide Business and Technical System Owners in current expectation of Data Integrity
• Understand both technical and procedural requirements of Data Integrity in a PLC / HMI / SCADA / MES environment
• Manage work according to a schedule
• Manage quality actions in Trackwise
• Write and revises system administration SOP’s etc. for data integrity requirements

Magnitude & complexity
The focus of the function is to execute remediation actions that ensure that the core Computerized Quality Systems at JBV 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.

REQUIREMENTS

Minimum of Bachelor degree or equivalent in computer science or equivalent; supplemented with additional training or experience during work life.
Extensive, in depth up-to-date knowledge of manufacturing computerized quality systems and recent developments in this expertise area is a requirement.

Minimum experience:
• 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.

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

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SIRE Life Sciences®

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