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Validation Consultant

Eingestellt von Juice Resource Solutions Limited

Gesuchte Skills: Engineering, Consultant

Projektbeschreibung

Validation Consultant
Location: Antwerp Area
Rate: £45 - £55 p/h
Duration: 3 months Initially

OVERVIEW:
To provide support for the validation activities associated with OSISoft PI ensuring that all compliance issues and requirements of our Clients Validation Policies and Procedures are addressed.

KEY ACCOUNTABILITIES: (OSISoft test/validation support)
- Execute test sets in HP/QC related to the validation of OSISoft PI system
- Complete SDLC 6.0 assets used to validate the OSISoft PI system and residing in the Docspace system
- Suggest and sometimes may implement innovation and continuous improvement within the Validation process
- Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
- Facilitates successful team behaviour within Quality Systems and across functional areas
- Manages relationships externally and internally.
- Fosters harmony within Quality Systems.
- Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
- Ensure that all validation activities are carried out and reported in a timely manner.
- Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
- Lead by example, inculcating the Credo values in all actions within the workplace

TECHNICAL PROFILE REQUIREMENTS:
- Knowledge of GAMP5 based validation.
- HP QC/Docspace
- Basic knowledge of OSISoft PI software

DESIRABLE:
- Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
- High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
- Working experience of validation computer systems for use in a FDA regulated environment.

NON-TECHNICAL PROFILE REQUIREMENTS:
- Individual must also be an active team member in Validation activities
- Good Document Practices.Strong analytical and problem-solving skills
- Must be able to work on multiple simultaneous tasks with limited supervision
- Quick learner, motivated self-starter
- Structured/Organized
- Excellent customer service, interpersonal, communication and team collaboration skills
- Able to follow and execute test (management) procedures and internal guidelines

Methodology/Certification requirements
- Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience. Advanced course work in technical systems plus continued education in technical disciplines is preferred
- English spoken and written
- Dutch is a plus

Projektdetails

  • Einsatzort:

    Antwerpen, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    3 months Initially

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Juice Resource Solutions Limited