SUS Qualification & Validation Specialist

SUS Qualification & Validation Specialist

Marietta, Pennsylvania

Long Term Contract

Requirement Scope:

Client is seeking services to manage the qualification documentation process for Single Use Systems (SUS) as part of a new product introduction. The scope includes drafting, reviewing, updating, and obtaining approval for various SUS qualification documents, such as Design Summary Reports, FMEA Use/Design documents, User Requirement Specifications, Design Qualifications, Leveraging Reports, and Installation/Operational Qualification Protocols and Reports. The project requires strict adherence to defined timelines, governance through regular meetings, and compliance with GSK's documentation standards to ensure approved deliverables that support product quality and regulatory requirements.