The primary objective of this position is to facilitate Smithfield NSW **** based complementary manufacturer in their relevant processes and systems to comply with local regulatory requirements and relevant authority in Australia.
Core Job Responsibilities:
List the primary tasks or activities this job performs
Lead the completion of the in-house QC laboratory setup.
Prepare and maintain documentation required for TGA laboratory licensing.
Coordinate laboratory qualification, validation, and commissioning activities.
Ensure the laboratory complies with TGA GMP and relevant regulatory requirements.
Support TGA inspections and respond to regulatory observations where required.
QC Manager with Lab testing experience
Job Purpose and Scope:
The primary objective of this position is to facilitate Smithfield NSW **** based complementary manufacturer in their relevant processes and systems to comply with local regulatory requirements and relevant authority in Australia.
Core Job Responsibilities:
List the primary tasks or activities this job performs
Laboratory Establishment & Licensing
Lead the completion of the in-house QC laboratory setup.
Prepare and maintain documentation required for TGA laboratory licensing.
Coordinate laboratory qualification, validation, and commissioning activities.
Ensure the laboratory complies with TGA GMP and relevant regulatory requirements.
Support TGA inspections and respond to regulatory observations where required.
Quality Control Operations
Manage daily laboratory operations and testing activities.
Review and approve laboratory data and test results.
Ensure timely testing of raw materials, packaging materials, in-process samples, finished products, and stability samples.
Maintain laboratory equipment qualification, calibration, preventive maintenance, and basic troubleshooting of laboratory instruments.




Oversee OOS, OOT, deviations, investigations, CAPA, and change controls relating to QC.
Method Development & Validation
Develop, verify, validate, and transfer analytical test methods in accordance with TGA and ICH requirements.
Prepare and review method validation protocols and reports.
Investigate analytical issues and implement appropriate corrective actions.
Provide technical support for laboratory instrumentation and liaise with external service providers when required.
Quality Systems
Develop, implement, and maintain QC SOPs and laboratory procedures.
Maintain documentation in accordance with GMP and data integrity requirements.
Ensure compliance with ALCOA+ data integrity principles.
Support internal audits, supplier audits, and external regulatory inspections.
Team Leadership
Recruit, train, and supervise laboratory personnel.
Develop staff competency and ensure ongoing GMP training.
Foster a culture of quality, compliance, and continuous improvement.
Cross-functional Support
Work closely with the QA Manager to support day-to-day quality activities and maintain the effectiveness of the Quality Management System (QMS).
Provide technical support to Production, QA, and Regulatory Affairs where required.
Participate in continuous improvement initiatives and support current product development and method transfer.
Knowledge / Education Required:
Minimum Bachelor of Science or Engineer or equivalent.
Experience Required:
Hand on experience required in QC level to perform this job.
Must have been a QC/lab testing experience in complementary industry with minimum 1 years experience.
KnowledgeofAustralian Health AuthorityTGAregulationsa must with understanding of basic principles in HACCPpreferable.
Preference will be provided to candidates with previous experience in a complementary manufacturing facility.
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