Description
For our client, a major pharmaceutical company, we are looking for a
Senior CSV Specialist / Validation Lead (m/f)
Reference: -en
Start: 06/17
Duration: 10 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 give 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 company 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 provide input to Informatics process improvement projects and other cross functional programs
Your qualifications
- Very good understanding of CSV in a pharmaceutical MES with profound experience in that area
- Strong experience in validation for MES projects
- Ability to communicate clearly 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 and German (written and spoken)
- PM experience
Skills:
- Auditor