Tasks & Responsibilities

• Managing all quality aspects including technical Quality Agreements and product listing update.
• Third party management including supplier qualification and risk assessments, Supplier Quality Audits, Vendor Qualification, Vendor Management.
• Internal and external audit activities and follow up on corrective actions ensuring continuous improvement of systems and procedures.
• Complaint handling.
• Batch release management.
• Stability program management.
• Writing and drafting processes, preparation and review/approval of area documentation (SOPs, methods), Training.
• QMS Maintenance, implemented QMS on site.
• Audit of production and QC documentation
• Assist the assessment and management of documents of the quality system e.g. deviations, change controls and CAPAs
• Assist in internal audits and in the review of validation reports

Selection Criteria

• Tertiary qualified in complementary science or related discipline
• Previous experience in the Pharmaceutical industry in a QA role
• Previous experience in the assessment of deviations, change controls and CAPAs
• Demonstrated knowledge of quality systems
• Excellent written and verbal communication skills
• High attention to detail
• High motivation, flexible and adaptable
• Computer literacy including Word and Excel knowledge
• Eligible working visa in Australia

Job Types: Full-time, Permanent
Pay: $55,000.00 – $70,000.00 per year

Language:

• Mandarin (Preferred)

Work Authorisation:

• Australia (Preferred)

Work Location: In perso

• Managing all quality aspects including technical Quality Agreements and product listing update.
• Third party management including supplier qualification and risk assessments, Supplier Quality Audits, Vendor Qualification, Vendor Management.
• Internal and external audit activities and follow up on corrective actions ensuring continuous improvement of systems and procedures.
• Complaint handling.
• Batch release management.
• Stability program management.
• Writing and drafting processes, preparation and review/approval of area documentation (SOPs, methods), Training.
• QMS Maintenance, implemented QMS on site.
• Audit of production and QC documentation
• Assist the assessment and management of documents of the quality system e.g. deviations, change controls and CAPAs
• Assist in internal audits and in the review of validation report