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Computer Systems Validation Specialist

Eingestellt von Michael Bailey Associates - Zurich

Gesuchte Skills: Client

Projektbeschreibung

For our life science client we are looking for a

COMPUTER SYSTEMS VALIDATION SPECIALIST

Start date: ASAP
End date:31.12.2017
Location: Basel area

We are looking for a Validation Lead who will be working for the Global Solution Center - Manufacturing IT supporting Pharma Global Technical Operations at Kaiseraugst and Basel, Switzerland.

The main focus of this position will be MES (Manufacturing Execution System). In addition there will be topics around Shop Floor Serialization, Data Analytics and Reporting Solutions.

Responsibilities:

- Leads a project stream for validation with the objective to set up the CSV of a MES Program (initial Core validation + rollouts) or ensures the completion of CSV deliverables in time and in quality o
- Authors, reviews and consults on validation documentation including but not limited to Test Scripts, Validation Plans, Installation Qualifications, SATs, UATs and Validation Reports
- Ensures compliance with corporate and global standards policies
- Escalates non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution
- Provides advice, expertise and trains others in the requirements for Quality Assurance and provides input to Informatics process improvement projects and other cross functional programs

Must Haves:

- Very good understanding of CSV in a pharmaceutical MES (+7 years of work experience in the relevant area)
- Experience in validation for MES projects (+5 years of work experience)
- Fluent in English and German (written and spoken)
- Flexible for business travels (up to 20%)
- Pharma experience

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    9.5 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

Michael Bailey Associates - Zurich