Senior CSV Specialist / Validation Lead (m/f)

REFERENZNUMMER:

331498/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Auditor