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Validation Officer-TGA Regulated Products
2 weeks ago
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
