Senior Laboratory Quality Officer

Sonic Clinical Trials

Ryde

Sur place

AUD 90 000 - 120 000

Plein temps

Il y a 2 jours
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Résumé du poste

Sonic Clinical Trials invites applications for an experienced Senior Quality Officer to join the Macquarie Park, NSW team on a 6-month fixed-term contract, with potential extension or permanency. You will oversee key quality systems, manage non-conformances, audits, document control and validation activities, ensuring a robust quality culture across the business.

The role requires tertiary QA qualifications, knowledge of NATA/ISO, GCP, CSV in QA, and strong communication to engage stakeholders

Qualifications

  • Tertiary qualifications in quality management/related field.
  • Experience with QA systems in regulated environments (pathology/pharma/healthcare) is essential.

Responsabilités

  • Day-to-day management of key quality systems (non-conformances, complaints, document management).
  • Audit management and archive control.

Connaissances

Quality management systems
GCP experience
CSV validation
NATA/ISO knowledge
Communication skills

Formation

Tertiary QA qualifications

Outils

MS Office

Description du poste

Sonic Clinical Trials – Macquarie Park NSW

Sonic Clinical Trials (SCT) is a leading provider of central and local laboratory services supporting pharmaceutical, biotechnology & medical device clinical trials, and a wholly owned subsidiary of Australian-owned Sonic Healthcare, one of the world's largest specialist medical diagnostics companies.

As we continue to grow and explore global opportunities, we have an outstanding opportunity for an experienced Senior Quality Officer to join the team on a 6 month fixed term contract, with the possibility of further extension or permanency.

This exciting role will appeal to professionals with strong quality management experience, preferably in a pathology laboratory or in a highly regulated laboratory environment. The successful candidate will support local and global projects, ensuring a quality culture throughout the business.

The position is based within a dynamic team environment at our Macquarie Park Head Office.

Key Responsibilities
  • Day to day management of key quality systems including:
  • Non-Conformances and Complaints Management
  • Document Management
  • Audit Management
  • Archive Management
  • Laboratory Quality Control and Validation documents
  • Change Control
  • Training & Compliance
Requirements
  • Tertiary qualifications, as well as previous quality management systems experience (within the pathology/pharmaceutical/healthcare services industry)
  • Experience working with NATA, ISO and strong working knowledge of GCP required
  • Experience in computer system validation (CSV) in a QA role
  • High level of computer literacy (e.g. MS Office suite or equivalent)
  • Excellent communication skills, both written and oral (with the ability to influence stakeholders across the business)
  • As a team member you will need to have exceptional interpersonal and people skills, show initiative, have exceptional attention to detail, able to manage competing priorities and deadlines, achieve, and deliver outcomes.

Background checks, including a National Police Check, will be required prior to commencement.

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