Key Responsibilities
* Act as the QA Qualification representative within project teams for new facilities and projects, ensuring compliance in the qualification of facilities, utilities, equipment, and systems
* Coordinate and align diverse QA interests throughout the project lifecycle, including processes and cleaning strategies
* Drive the execution of a new qualification strategy, making informed decisions as necessary
* Compile, review, and release essential qualification documents such as URS, Qualification Plans & Reports, and DQ/IQ/OQ/PQ Reports while supporting quality risk analysis (e.g., FMEA)
* Conduct assessments and approve technical change requests relevant to the qualification of various systems and equipment during different project phases
* Represent qualification aspects during audits by customers and regulatory bodies
* Lead CAPA initiatives and Effectiveness Checks to ensure timely resolution and appropriate documentation of deviations in Deviation Reports