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IT Compliance Consultant

Eingestellt von Harvey Nash IT Recruitment Belgium

Gesuchte Skills: Consultant, Support

Projektbeschreibung

Our client is a multinational pharmaceutical located in Walloon Brabant and is looking for an IT COMPLIANCE CONSULTANT. The IT QA CONSULTANT will provide IT COMPLIANCE expertise to the COMPLIANCE team and will be located in Walloon Brabant for at least 6 months.

Scope of work:

- As QA IT COMPLIANCE expert, the candidate will be able to:
- Advise and orient each Business Unit whatever the Computer Related System category: Laboratory, ATS, ANS, AMS, PLC, IT Central systems (SAP, Documentum), LIMS (Labware)
- Assist the QA COMPUTER COMPLIANCE Manager to supervise COMPUTERIZED OR AUTOMATED SYSTEMS VALIDATION PROJECTS.
- Actively participate and initiate workgroups related to validation strategies or methodologies for COMPUTERIZED/AUTOMATED SYSTEMS in the R&D environment.
- Interpret REGULATORY REQUIREMENTS for their application in R&D environment
- Approve procedures, validation protocols, validation results and conclusions
- Assure final approval of the validation processes and documentation.
- Ensure QA requirements for automatic and analytical systems are covered (procedure approval, validation methodology).
- Review and approve deviations and change control for critical systems.
- Support GXP decisions/strategies during validation projects.
- Establish SOPs for quality standards in collaboration with other departments based on Global Quality Assurance and or corporate policies.
- Ensure all QA requirements for IT quality system, with potential GXP impacts, are met (procedure approval, validation methodology, deviations, change control and audit)
- Ensure that the GMP requirements for critical systems are covered and approved (SAP, Documentum, Peoplesoft, other applications developed on IT platforms).
- Provide QA expertise and support to related teams.
- Guarantee that the R&D data generated electronically is obtained, used and archived in accordance with GXP and Good scientific practices, corporate and international regulations.
- Monitor the quality and accuracy of the data used in drug discovery.
- Assure harmonization of practices in the team and between other QA teams.
- Contribute to standardize processes and approaches for different systems and for different sites.

Requirements:

- Bachelor degree in computer engineering, industrial technology, chemistry or biotechnology
- Knowledge of R&D environment is mandatory.
- Knowledge on CSV Validation is mandatory with experience on Spreadsheets validation (Excel, SofMaxPro).
- Knowledge of compliance rules and recommendations for CSV area (21 CFR PART 11, GAMP) and for Business in pharmaceutical industries (GLP, GCP, GMP)
- At least 3 years of experience in IT OR COMPLIANCE ENVIRONMENT.
- Knowledge on Risk Management is an asset.
- Fluent in spoken and written English both scientifically/technically as well as conversational.
- Good capacities of communication are expected as well as open-minded behavior to ensure the 'fit for purpose' requirements level.

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Belgium