Job Title: CSV Lead
The primary objective of this role is to spearhead the overall CSV approach and validation methodology.
Responsibilities:
* Ensure that the CSV program is executed in accordance with relevant site procedures and applicable regulations.
* Provide guidance to resolve issues as they arise, ensuring solutions are managed collaboratively.
* Manage stakeholders at monthly reporting meetings, fostering a collaborative environment.
* Prepare and approve all key documentation, providing guidance to ensure team alignment with project document schedules.
A successful candidate will have extensive knowledge and proficiency in GXP system operation (Automation/IT) and Validation, including operational & data lifecycle requirements as they relate to GXP computerised Equipment/Systems. The ideal candidate will also possess experience delivering a comprehensive suite of validation documentation relating to GXP control system introductions / changes.