1        KEY RESPONSIBILITIES

• 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. 
• Qualification of temperature‑controlled unit.