Specialist Laboratory Data Integrity

Werkgever CheckMark Labrecruitment
Plaats Regio Leiden
Provincie Zuid-Holland
Dienstverband Voltijd (> 36 uur)
Contract Tijdelijk
Plaatsingsdatum vrijdag 5 januari 2018
Sluitingsdatum vrijdag 2 februari 2018

Direct solliciteren

Functieomschrijving

You are responsible for GMP-level computerized quality systems and help to ensure that data integrity meets the regulatory and funcitonal requiremnets. You offer guidance regarding data integrity, gap analysis and remediation actions to the business and technical system owners 

As Specialist Laboratory Data Integrity you work within the site data integrity project for manufacturing and production systems. You identify gaps and work on projects to ensure that computerized quality systems meet the current requirements of data integrity. For this purpose you work in multidisciplinary project teams



- You organize meetings to assess the data integrity of production systems. You provide guidance to business and technical system owners in change and remediation tracks
- Working with both the technical and procedural requirements of data integrity  you help to improve several applications such as Manufacturing execution systems (MES), Supervisory control and data acquisition (SCADA), Programmable logic controller (PLC) and Human-machine interface (HMI)
- Moreover, you review quality actions in Trackwise, and you write/revise system administration standard operating procesdures (SOP's) for data integrity requirements
- The complexity and challenge for you as Specialist Laboratory Data Integrity lies 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

Profiel

Opleiding HBO
Ervaring Ervaren (3 - 8 jaar)
As Specialist Laboratory Data Integrity you have the following qualifications and experience:

- Minimum of Bachelor degree or equivalent in computer science or equivalent; supplemented with additional training or experience 
- At least 4 years of relevant experience in the pharmaceutical or related industry of which a substantial part in computerized systems, data integrity and/or related functions
- This allows you to bring knowledge of manufacturing computerized quality systems and recent developments in this expertise area 
- You have experience in a complex, multinational work environment/company and thus project management skills and interpersonal skills
- You are able to communicaite with personnel at all levels within the organization. Your written and oral communication skills in English are excellent. Dutch language knowledge is preferable

Aanvullende informatie

- Secondment via Checkmark Labrecruitment 
- This assignment is for 12-18 months total
- Minimal of 32 hours per week. Preferably full-time

Contact

Neem voor meer informatie contact op met  Coen Smiers: 0182 590 218 // 06 218 999 66
Vacaturenummer: 5634

Bedrijfsprofiel

A large biopharmaceutical company

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