QA Associate: Complaints & GMP Compliance

Probiotec; City of Melbourne; Vor Ort; AUD 65.000 - 105.000; Vollzeit

Zusammenfassung

Probiotec is seeking a Quality Assurance Associate focused on complaints to strengthen our GMP-compliant QA systems across its Australian sites. You will investigate complaints, coordinate with departments to implement corrective actions, and support audits and the maintenance of QA documentation.

Ideal candidates hold a science degree with experience in QA, GMP/GLP knowledge, and strong communication skills.

Qualifikationen

• Bachelor's degree in Science or related field is preferred.
• Experience implementing corrective action programs and QA methodologies.
• Professional scientific competency in QA principles.
• Understanding of GMP, GLP and regulatory affairs.
• Strong organizational and time management skills.
• Excellent communication and report writing abilities.
• Ability to apply QA frameworks and systems in pharmaceutical environments.
• Teamwork and cross-functional collaboration across levels.
• Ability to work both in a team and autonomously.
• Willingness to learn new QA methods and manage multiple tasks.

Aufgaben

• Manage, investigate, and respond to customer complaints and inquiries with timely documentation and root-cause analysis.
• Assist Quality Manager with maintenance of QA systems to ensure GMP compliance.
• Coordinate mock recalls and assess recall effectiveness.
• Audit manufacturing/packaging batch records for GMP compliance and release for supply.
• Ensure batches follow SOPs and batch record requirements.
• Prepare/Review SOPs as needed.
• Perform deviation investigations and document issues.
• Prepare change controls, temporary variations, and risk assessments.
• Monitor corrective actions and assess effectiveness.
• Assist with cleaning validation data collection and reporting.
• Approve GMP documentation including specs, sampling, test methods, SOPs, deviations, and change controls.
• Manage Deviations, CAPAs and Change Requests.
• Prepare reports and data for Product Quality Reviews.
• Assist in vendor assurance program management.
• Prepare monthly reports for Quality Manager.
• Conduct internal audits to ensure GMP compliance.
• Other duties as assigned by the Department Manager.

Kenntnisse

Strong organizational & time mgmt

Communication & report writing

Teamwork

Autonomy

Learn new methods

Ausbildung

Bachelor's degree in Science or related field

Jobbeschreibung

Probiotec is seeking a Quality Assurance Associate focused on complaints to strengthen our GMP-compliant QA systems across its Australian sites. You will investigate complaints, coordinate with departments to implement corrective actions, and support audits and the maintenance of QA documentation.

Ideal candidates hold a science degree with experience in QA, GMP/GLP knowledge, and strong communication skills.