Develop and execute validation (IQ/OQ/PQ) / study protocols as performer or witnessed by (depending on assignment) against approved URS and risk assessments.
Lead or support risk assessments and impact assessments where applicable.
Initiate change control process for any modifications affecting validated state.
Plan, manage and coordinate activities with other functions including equipment suppliers, Engineering, Manufacturing, QC, QA.
Track the CQV deliverables and ensure adherence to schedule from project to operation readiness.
Ensure traceability across lifecycle documents.
Lead resolution of variation / deviation investigation in a timely and compliant manner.
2 SCOPE OF WORK
Qualification of clean air equipment, such as VBE (ventilated balance enclosure / negative pressure hood) etc.
Qualification of sterilization cycle (CD, PQ) of autoclave loads.
