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Senior Computer Systems Validation Lead (Scientific & Manufacturing)

Eingestellt von 7N Switzerland Ltd

Gesuchte Skills: Client

Projektbeschreibung

We are looking for a Senior Computer Systems Validation Specialist as Validation Lead (Scientific & Manufacturing) as follows:

GENERAL INFORMATION:

- Location: Basel area
- Travelling: Some travel (max. 20%, possibly to Germany) may be required.
- Workload = 100% (potentially start with a lower workload, then ramp up to 100%)
- Extension: An extension might be possible, but would need to be approved.

BACKGROUND:

We are looking for a Validation Lead who will be working for the Global Solution Center - Manufacturing IT supporting Pharma Global Technical Operations of our client in the Basel area. 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)

o Ensures the completion of CSV deliverables in time and in quality

o Ensures the alignment of the different stakeholders

o Collaborates with and gives regular updates to the Project Manager

- 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 company standards (eg internal CSV policies, directives and SOPs or project management methodology) and legal requirements
- 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)!
- Ability to communicate clear and effectively
- Ability to arbitrate between a wide range of stakeholders to come to a solution (former work experience with stakeholders would be a big plus)
- Strong leadership skills (former work experience as a lead would be a big plus)
- Fluent in English (written and spoken)
- Flexible for business travels (up to 20%)

NICE TO HAVES:

+++ Experience in CSV for a global program understanding of the MES

+++ process

++ German speaking

++ Project management experience

If you meet the requirements and if you are interested please mail your CV and your desired hourly rate to (see below) as soon as possible, latest by 9.3.:00.

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    31.12.2017

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

7N Switzerland Ltd