Validation & Qualification:

Develop and execute protocols for equipment qualification (IQ/OQ/PQ)

Conduct manufacturing process validation and cleaning validation

Prepare and maintain the Validation Master Plan (VMP)

Perform HVAC, water, compressed air, and chiller system qualifications

Execute and manage calibration activities for critical instruments

Ensure TGA compliance in all validation documentation and practices

Audits & Compliance:

Support and participate in internal audits

Assist in external audits including TGA and other regulatory bodies

Lead and support analytical method validation and computer system validation

Quality Systems:

Manage validation-related activities within the Quality Management System (QMS)

Handle change control, deviation investigations, CAPA, and non-conformance reports

Collaborate with cross-functional teams to ensure timely closure of quality events