Lead CSV Validator
A pharmaceutical company is seeking a Lead CSV Validator to join their Capital Project Team. The successful candidate will be responsible for leading and guiding the qualification of GxP Computerised Systems.
* The ideal candidate will oversee the overall CSV approach and validation methodology, ensuring it aligns with site procedures and applicable regulations.
* They will provide guidance on issue resolution, stakeholder management at monthly reporting meetings, and preparation of key documentation.
* Closely collaborate with engineering disciplines and vendors to ensure deliverables meet qualification requirements.
Main Responsibilities:
* Develop and execute Change Controls and Trackwise records for system updates/changes.
* Establish GXP System specifications and Standard Operating Procedures (SOPs) to adhere to industry standards.
* Draft new or update existing risk assessments to support GXP system operation as they relate to validation/regulatory requirements.
* Maintain Requirements Traceability Matrix and generate Data Lifecycle maps as per site requirements.