Pharmaceutical Quality Assurance Specialist

3 days ago

Adelaide, South Australia Programmed Full time

About Programmed

We are seeking a highly skilled Pharmaceutical Quality Assurance Specialist to join our team in Australia. 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: Ensure compliance with cGMP standards, regulatory requirements (TGA, FDA, AQIS), and Standard Operating Procedures (SOPs).
  • Maintenance and Reconciliation: 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.
  • eDMS Support: Support the eDMS system, including TrackWise Digital and ComplianceWire.
  • Training and Development: Assist departments in creating training curriculums and documentation. Provide training on GMP requirements as needed.
  • CAPA Representation: Represent QA in CAPA incidents, risk assessments, and corrective/preventive action agreements.
  • Audits and Assessments: Participate in internal and external audits, including TGA and DA inspections. Assist in validation impact assessments, FMEAs, and QA reviews of validation documents.
  • Supplier Management: Track and manage external suppliers, ensuring supplier assessments, reviews, Quality Agreements, and audits are up-to-date.
  • Quality Reviews: Conduct Annual Product Quality Reviews.

Skills and Experience:

  • Proven Experience: Proven experience in Quality Assurance, preferably in a pharmaceutical or regulated manufacturing environment.
  • cGMP Knowledge: Strong knowledge of cGMP standards and regulatory compliance (TGA, FDA, AQIS).
  • Quality Systems: Skilled in managing quality systems, including eDMS, deviations, and CAPAs.
  • Training and Audits: Proficient in conducting training, audits, and risk assessments.
  • Attention to Detail: Exceptional attention to detail and ability to work across multiple sites.
  • Communication Skills: Excellent interpersonal and communication skills for cross-functional collaboration.

Compensation: The salary for this position is approximately $120,000 - $150,000 per annum, depending on experience.

This is an excellent opportunity to join a leading pharmaceutical company and contribute to the success of their Quality Assurance team. If you have the required skills and experience, please submit your application.

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