Search Jobs


Home-Based Senior Quality Assurance Associate / Australia

This job has expired or may no longer be taking applications, but other similar jobs are available.
 Click here to shortlist this job 1-CLICK Apply With Employer or Register Now
Location: Sydney, Australia
Salary:$80000 - $90000 per annum
An exciting opportunity to join an outstanding clinical research company. If you are self-motivated, experienced, and looking for a job that will expand your career then this might be the job for you.

Broad Purpose

The Home-Based Senior Quality Assurance Associate is responsible for contributing to the development, implementation and maintenance of the quality assurance program and related policies and procedures to ensure compliance with Good Clinical Practices (GCP) and other regulations.

Core Responsibilities

  • Manage the planning, conduct, reporting and closure of study audits to ensure that the study was conducted in compliance  with applicable regulatory and organisational procedures:
    • Auditing of Trial Master Files
    • Auditing of Study Databases
    • Auditing of Clinical Study Reports
    • Internal audits in accordance with approved Audit Schedule, facilitate internal facility, process and vendor audits.
  • Act as Audit Coordinator and host/ co-host 3rd party audits and inspections.
  • As required, contribute as a member of the investigational team for CAPAs.
  • Coordinate preparation, review and issue of Standard Operating Procedures (SOPs) to support and maintain quality systems.
  • Maintain an up-to-date knowledge of the latest requirements relating to GCP and regulatory requirements in Australia and overseas.
  • Other duties as directed by Line Management or delegate.
 Qualifications, Skills and Experience

  • Ordinary degree in the appropriate discipline (e.g. Bachelor of Science) or equivalent experience.
  • Minimum 4-5 years’ experience as a Senior Quality Assurance professional in the pharmaceutical industry operating in a GCP or GxP environment.
  • Formal audit training or evidence based internal audit training.
  • Knowledge of 21 CFR Part 11 and its implementation.
  • Demonstrated ability to prioritise work and handle deadline pressure.

This is an opportunity with an organisation that doesn't just invest in transformative medicine but is also willing to invest in their people. 
If you think you have what it takes to take on this role, submit your CV to me.

How to Apply

Latest Jobs - general counselhelath & safety advisor - $120k - $130ksenior contract administrator - up to $170kproject engineer - up to $120k packagesenior contract administrator - up to $140,000 packagehealth & safety advisor - $100k - $120kconstruction managerlandscape designer and drafterhealth & safety advisor - $80k - $100khse coordinator - up to $160kproject manager - $200,000 packagedynamic positioning officerit electricianhead of engineeringsenior electrical engineersenior mining engineercontract: armo techniciandirector of architecturesenior principal estimator ($150000 - $180000 per annum)contract: well servicing equipment operatorcontract: sr. electrical engineercontract: materials coordinatorcontract: category specialistcontract: maintenance ready for operations - electrical & instrumentation technical specialistcontract: expeditorcontract: project coordinatorcontract: electrical engineercontract: maintenance engineeercontract: process control systems engineer, hmi programmersenior manager - coworking provider (£180k per annum)contract: structural design engineercontract: technical architect contract: internet of things (iot) analystpatent attorneylearn arabiccontract: business system analyst/sc vendor managementcontract: web content producercontract: gs construction engineer greenfield - ffcontract: electrical certification engineerbuyers (procurement engineers)lead mooring engineercontract: manager - threat detectioncontract: 3gp mc engineercontract: cyber product specialistcontract: schedule controllerlegal managercontract: electrical inspectorcontract: mechanical engineergeneral manager - shippingcommercial project managerproject engineer
© All rights reserved, 2001 - 2020