Quality Assurance Specialist

 Australia, Sydney, New South Wales
 4 days, 23 hours ago

Our client

An internationally recognised pharmaceutical company that produces many of the world's best-known consumer health care products, medicines and vaccines. Our Client is seeking an exceptional Quality Assurance Specialist to take on a role that offers a range of strategic and operational responsibilities in a dynamic, fast-paced environment.

Duties include but not limited to:

  • Authorise the Release for Supply of products
  • Review batch manufacturing records for products released under the company license
  • Review COA, COC, packaging artwork and any other relevant documentation of finished products
  • Execute, review and ensure any associated deviations are closed
  • Compile Batch Release reports for submission to the TGA and liaise with the Regulatory Affairs to address TGA requests related to Annual Product Quality reports
  • Review and approve documentation related to Release of Supply function as part of Marketing Authorisation
  • Develop, review and prepare internal documents such as SOP's and create and review SCQ documents
  • Carry out and assist in performing QRM assessments for changes and deviations as necessary, internal and external audits and review, create and approve GMP audit reports
  • Contribute in trouble shooting investigations and lead quality risk assessments
  • Initiate Continuous Improvement for processes and systems and take part in Action / Product Recalls
  • Ideally you will have:

  • Tertiary qualification in Science
  • A minimum 3 years' experience in a Quality Assurance role
  • Sound experience and knowledge of GMP and regulatory requirements
  • Good understanding of Manufacturing processes
  • Ability to work independently and in a team environment
  • Strong analytical, investigation, problem solving and decision making skills
  • Strong planning and organisational skills with the ability to multitask and follow tasks through to completion
  • Excellent written and verbal communication skills
  • Strong attention to detail
  • If you meet the above requirements and are ready to join an organisation that improves the lives of people around the world and solves some of the world's most challenging healthcare problems, I would love to hear from you.

    To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Souraya Jumaah on 02 9432 3333.

    To view all Techstaff job opportunities visit www.techstaff.com.au

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