Tasks and Responsibility Develop, implement, and maintain a robust Quality Management System that complies with
both TGA regulations and GMP standards. Build on the existing Quality structure and
documents and add or improve where necessary.Design and conduct GMP-focused training programs for key personnel and managers,
implement training programs for production and other departments to ensure they adhere
to quality and safety standards.Lead the organization through TGA certification processes, ensuring audit readiness and
seamless compliance with all regulatory and quality standards. Conduct internal audits and
reviews to assess and enhance GMP compliance within all operational aspects.Lead Quality Management Review meetings.Implement supplier quality management programs in line with PIC/S requirements,
conducting audits and assessments to ensure supplier compliance. Address and resolve customer quality complaints, adhering to GMP and TGA standards. Work in collaboration with the Supply Chain, RD and Production team to prepare raw
material specifications, finished product specifications and batch manufacturing/packaging
instructions. Take leadership role in the Quality Risk Management and ensure risk assessment tools are
used across the QMS and decisions are made on a risk-based approach where necessary.Work in collaboration with the Supply Chain, RD and Production team to manage deviations,
non-conformances, change controls and drive continuous improvement by the
implementation of corrective actions and preventive measures.Ensure that all GMP documents are prepared, reviewed, approved, updated and archived in
accordance with the document control requirement. Maintain the GMP records and results
as per Data Integrity requirement.Lead Equipment Qualification/Cleaning Validation/Process Validation/Analytical Method
Validation/Revalidation.Offer expert advice and support on GMP and TGA compliance to internal teams and external
partners and facilitate compliance projects.Communicate with subcontractors, raw material suppliers, packaging suppliers, customers
and local/overseas regulatory authorities to enable delivery of the company strategic objectives and goals. Essential Requirements Tertiary degree in a relevant scientific, pharmaceutical, or engineering background.
Additional qualifications or certifications in quality management systems, regulatory affairs,
or a related discipline are highly desirable.A minimum of 8 years of experience within the pharmaceutical or biopharmaceutical
industry including at least 2 years of experience in senior quality management positions.Previous experience in implementing, managing, and enhancing Quality standards in
accordance with TGA guidelines and PIC/S requirement.Previous experience in TGA inspection/HACCP inspection/ISO inspections etc.Capable of independently lead Qualification and Validation activities.Demonstrate competency in statistical methods, data analysis and quality control processes
that are critical for ensuring product quality and safety.Candidates with experience and knowledge in both APIs and Finished Products
Manufacturing will be highly desirable.Advanced computer skills Microsoft Office Excel and Suite, and other tools relevant to
quality documentation and record-keeping.