QA Compliance Specialist

1 week ago

Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $120,000
Quality Assurance Associate Role Summary

This QA Associate role is a key position in our organization, responsible for ensuring the quality of our products and services. The successful candidate will have a strong background in quality assurance and a proven track record of implementing effective quality systems.

Job Description

The Quality Assurance Associate will be responsible for coordinating internal and supplier audits, vendor qualifications, and computer system reviews. This will involve managing the audit schedule, ensuring that all e-QMS systems and processes meet the required level of compliance.

The Quality Assurance Associate will also be responsible for:

  • Management of the internal and external audit program and acting as lead auditor in Internal and external audits.
  • Management of Computerised System Reviews eg. QC lab software such as Empower and SCADA.
  • Management of the Vendor Qualification program.
  • Contribution to the development and maintenance of cGMP compliance applicable to all relevant regulatory jurisdictions.
  • Tracking and management of maintenance of Issues/Actions in the Quality Management System (QMS) including follow-up on actions such as deviations, OOS investigations, audits, complaints, regulatory inspections.
  • Compilation of quality metrics and statistics as required.
  • Facilitation of QMS meetings and committees as required.
  • Maintenance of annual QMS schedules such as, internal and external audits, APQR, AQSR, GMP training, management inspections, media fill etc.
Required Skills and Qualifications

To be successful in this role, the candidate will require:

  • A Science degree or equivalent.
  • Experience in cGMP, pharmaceutical/medical device manufacturing environment.
  • Minimum of 3 years in Quality-related role in pharma/med device sector.
  • Experience with internal auditing and ability to write detailed audit reports.
  • Highly motivated individual. Ability to work autonomously and in team environment.
  • Effective communicator who can partner with all areas of the business.
About Our Company

We are an established and reputable global veterinary pharmaceutical manufacturer located in South Sydney. We have a market-leading portfolio for livestock, and companion animals. We are an FDA and EMA-accredited site.

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