Job Opportunity
Cross-Functional Validation Specialist
This role requires a skilled professional to lead and coordinate Cross-Functional Validation (CFV) activities. The specialist will be responsible for ensuring compliance with industry regulations and developing effective validation strategies.
Key Responsibilities:
* Guiding CFV Activities: Oversee the execution of solution preparation, guaranteeing timely completion and adherence to regulatory requirements.
* Protocol Development and Review: Create, review, approve, and execute commissioning, installation, and qualification protocols.
* Equipment Commissioning: Manage and coordinate Solution Prep equipment commissioning and qualification activities.
* Client and Stakeholder Liaison: Serve as the primary point of contact between clients, internal teams, and external vendors.
The ideal candidate will possess relevant qualifications and/or 10 years' experience in the biotech or pharmaceutical industry, with a strong background in qualifying GxP systems.