We are recruiting, on behalf of our client, a CSV Associate with experience in the pharmaceutical industry.
At this role, you will be responsible for the CSV activities on the laboratory and manufacturing equipments.
- Define the validation strategy and author key validation deliverables for multiple systems in areas such as: laboratory instruments software, electronic logbooks, GMP data collection middleware, etc.
- Directly responsible for completing system impact/risk assessments and data integrity assessments, for authoring validation plans, test plans, requirements traceability matrices, validation summary reports, etc.
- Leveraging the existing Validation Master Plan, validation SOPs and Data Integrity assessments defined at enterprise level.
- Define the validation approach for change controls based on scope and risk and help maintain validated state for regulated systems.
- Contribute and collaborate on CSV activities for enterprise-level, multi-site lab and manufacturing systems.
- Work collaboratively to ensure the development of CSV best practices to support the timely delivery of validated computer systems for internal clients.
- Fluency in English and French is mandatory.
- Communication with US counterparts, particularly the CSV team.
- Lead presentations to review the CSV activity in Geneva or to help improve CSV practices.
- BS or relevant degree with at least 4 years of CSV experience in a GxP environment in the pharmaceutical industry.
- Experience defining the validation approach for computer systems.
- Excellent knowledge of Part 11 and Annex 11 regulatory requirements as well as Data Integrity expectations. Experience ensuring these requirements are specified, fulfilled, and tested for regulated computer systems.
- Experience working with laboratory instruments and manufacturing systems and validating the associated software is desired.
- Ability to prioritize, good written and verbal communication skills.