Beschreibung
Senior CSV Specialist - Basel - 100%
If you are a Senior CSV Specialist with MES and pharma experience, then you are THE person we looking for!
This very exciting opportunity is a contracting position planned to start the 13th March until the 31st December for one of the biggest pharmaceutical players based in Basel.
Background:
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.
The project:
- 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:
- 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 recognize yourself in this profile, so please don't hesitate to send me your CV at I look forward to receive your application!
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