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Data Integrity Specialist SME 31451

  • Contract
  • competitive
  • Leiden, South Holland
  • IT

Currently I am recruiting for two different Data Integrity Specialist who will work within the site Data Integrity project for manufacturing / production systems. You will analyse data integrity gap assessments and proposes solutions, organise site resources for remediation and remediate systems gaps. Offer guidance regarding data integrity gap analysis and remediation actions to the DI Remediation Project Lead, Business and Technical System Owners. Proposed timeline is until the end of the year. Based in Leiden. Interested? Let me know: s.kolks[at]realstaffing.com or call me on 020 522 1588 #dataintegrity #itmanagement #pharmacy

1. Data Integrity Specialist SME (more senior role)
Job description:
Works 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.

Principal 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
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.

Extensive, in depth up-to-date knowledge of manufacturing computerized quality systems and recent developments in this expertise area is a requirement.

Experience and background sought:
* 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.

2. Data Integrity Specialist Remidiation (follows guidance from DI SME):
Job description:
Works within the site Data Integrity project for process automation and IT systems. Implements changes to system documentation following the analysis of data integrity gap assessments. Executes and reports periodic reviews of process automation and IT systems according to predefined processes. Works with the DI SME to offer guidance regarding data integrity gap remediation actions to the Business and Technical System Owners.

Principal responsibilities
* Write and revise system SOP's / systems administration SOP's etc… to include data integrity requirements
* Analyse data integrity gap analysis results, propose and execute remediation actions
* Guides Business and Technical System Owners in current expectation of Data Integrity
* Understands both technical and procedural requirements of Data Integrity in a production system / PLC / HMI / SCADA / MES environment
* Manages work according to a schedule

The focus of the function is to execute remediation actions that ensure that the 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 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.

Experience and background sought:
* 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 2-4 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.
* Pro Active, works independently, takes actions in the absence of specific instruction
* Excellent communication and advisory skills, result oriented.