Pharmaceuticals & Medical Devices (Healthcare & Medical)
Full time
Our client is seeking a highly skilled Senior Quality Assurance Officer to join a leading pharmaceutical company. This role is instrumental in supporting the management of the Quality System and electronic Document Management System (eDMS). You will work closely with the Quality Manager and the broader Quality Department across multiple sites, ensuring compliance with stringent regulatory standards.
About the role: Ensure compliance with cGMP standards, regulatory requirements (TGA, FDA, AQIS), and Standard Operating Procedures (SOPs).Maintain manufacturing records and allocate batch numbers for scheduled immunisations, bleeding, and serum production.Reconcile and close deviations, CAPA, and other batch-related discrepancies promptly.Support the eDMS system, including TrackWise Digital and ComplianceWire.Assist departments in creating training curriculums and documentation.Provide training on GMP requirements as needed.Represent QA in CAPA incidents, risk assessments, and corrective/preventive action agreements.Participate in internal and external audits, including TGA and DA inspections.Assist in validation impact assessments, FMEAs, and QA reviews of validation documents.Review Sheep Health Status Notifications.Track and manage external suppliers, ensuring supplier assessments, reviews, Quality Agreements, and audits are up-to-date.Conduct Annual Product Quality Reviews.Skills and Experience: Proven experience in Quality Assurance, preferably in a pharmaceutical or regulated manufacturing environment.Strong knowledge of cGMP standards and regulatory compliance (TGA, FDA, AQIS).Skilled in managing quality systems, including eDMS, deviations, and CAPAs.Proficient in conducting training, audits, and risk assessments.Exceptional attention to detail and ability to work across multiple sites.Excellent interpersonal and communication skills for cross-functional collaboration.HOW TO APPLY You must have the right to live and work in Australia to apply for this role. Click "APPLY NOW" to register for this role or contact San Wong at ****** and quote reference - 210277033 for any enquiries. Please note that due to the high volume of applicants, only shortlisted candidates will be contacted.
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