Senior Computer Systems Validation Specialist

SENIOR CSV SPECIALIST - BASEL - 100%

Experis is the global leader in professional resourcing and project-based workforce solutions. Our suite of services range from interim and permanent recruitment to managed services and consulting, enabling businesses to achieve their goals. We accelerate organisational growth by attracting, assessing and placing specialised professional talent.

For our international client based in Basel, Experis is currently looking for a Senior CSV Specialist.

General information:

- Preferred start date: 04.09.2017
- Latest start date: 11.09.2017
- End date: 31.12.2018
- Work location: Kaiseraugst, Basel
- Travelling: Some travel (max. 20%) may be required (to vendors in Germany, eg Karlsruhe).
- Remote/Home Office: Possible max. 1 day per week, other days 100% onsite.
- Workload: 100% (potentially start with a lower workload, min. 80%, and then ramp up to 100%)
- Additional information: Team of ca. 20 team members.

Tasks & 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 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

You bring for this role the following qualifications:

Must Haves:
- Very good understanding of CSV in a pharmaceutical MES (+7 years of work experience in the relevant area)
- Strong project management skills and delivery focused (+5 years of PM experience)
- 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

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However should you have any questions please contact Stéphanie Vogt.