Quality Assurance Associate

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Irfa******

  • Australia 
  • Last Update: 24.10.2018 at 12:00

Job Type
Full Time
Start
ASAP
Duration
13 Month +
Place
Sydney, AU
Country
Australia

Category


Regulatory, Quality and Clinical

Description


About The Opportunity

The Quality Assurance team are seeking a likeminded professional who can hit the ground running in a pharmaceutical Quality Assurance Associate role. You will report directly to the Quality Manager and the main focus will be providing an oversight of product quality from the contract manufacturers.
Duties
Quality oversight of Contract/External manufacturers
Product release - auditing and evaluation of batch documentation in line with TGA
Writing and review of SOPs, PQR, deviation and investigation reports
Create reporting through SAP and master spreadsheets
Management of the Quality Management System (QMS)
Maintain communications with external manufacturers
Skills and Experience
2-3 years' experience in a QA Assurance role in the Pharmaceutical industry
Strong understanding of GMP and GLP
Product release experience - essential
Change control experience - essential
Knowledge of Deviations, NCR

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