Description
For our client a pharmaceutical company we are looking for a
Senior Computer Systems Validation Specialist (m/f)
Reference: -en
Start: 09/17
Duration: 15 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Lead a project stream for validation with the objective to set up the CSV of a MES Program (initial Core validation + rollouts)
- Ensure the completion of CSV deliverables in time and in quality
- Ensure the alignment of the different stakeholders
- Collaborate with and gives regular updates to the Project Manager
- Author, review and consult on validation documentation including but not limited to Test Scripts, Validation Plans, Installation Qualifications, SATs, UATs and Validation Reports
- Ensure compliance with corporate and global standards
- Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution
- Provide advice, expertise and train others in the requirements for Quality Assurance and provides input to Informatics process improvement projects and other cross functional programs
Your qualifications
- Very good understanding of CSV in a pharmaceutical MES
- Strong project management skills and delivery focused
- Experience in validation for MES projects
- 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)
- Flexible for business travels (up to 20%)
- Experience in CSV for a global program
- Understanding of the MES process
- German speaking would be a plus
Skills:
- Business analyst
Keywords: Business Analyst