Search Jobs


Home-Based Senior Quality Assurance Associate / Australia

 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 - senior cementing engineer - offshorepre-commissioning managersubsea completions supervisorassociate director - railtelemetry managersenior reservoir engineersenior construction engineercontract specialist - bridge ($10-$15k per month)operations safety managerproject manager ($100,000 - $130,000 aud)senior project manager ($150,000 - $180,000 aud)senior drainage engineer ($100,000 - $150,000 aud)senior civil engineer ($100,000 - $120,000 aud)project engineer (up to $130,000 aud )estimator ($130,000 aud package)mechanical maintenance supervisorengineer ivcivil supervisorconstr mat spec iisenior piping engineersenior drilling engineerhead of engineering (€85000 per annum)senior equipment & well engineermine maintenance manager - world leading base metal producerproject surveyor / pqssenior planning engineersenior quantity surveyor / contracts managerlearn arabicquantity surveyor / contract administratorsite administration managerqa/qc engineerengineering surveyor - fifo from anywhere in australiaschedulerrig managerrecruitment officerprocess control engineer ($50 - $70 usd per hour)global engineering manager – valves & flow controlcontract advisorsite inspectortesting & commissioning manager - railsenior accountanttrack work design expert - head office ($10,000 - $11,000 usd per month)process engineersenior project engineer - water ($150,000 - 180,000 aud)tag & itools specialistqhse training officer project manager - up to $150k packageforeman - luxury homes ($110k - $125k aud )contract administrator ($55 to $65 per hour)contract administrator (up to $120k aud package)drafting coordinator - hvac ($75-$95k aud)
© All rights reserved, 2001 - 2019