Quality Assurance Associate

Work Type

Location

Closes

Full Time

NSW

30/04/2021

Job description

Qualifications & experience

  • Relevant tertiary university qualifications.
  • Thorough knowledge, understanding and experience of relevant guidelines.
  • Preferably 3+ years of pharmaceutical experience in quality assurance and compliance.
  • Strong communication, analytical and systems skills.

 

Tasks & responsibilities

  • Management of all company quality aspects; including technical quality agreements and other quality documentation.
  • Management of QMS; including issuing of controlled copies, updating controlled document database, filing and archiving of controlled documents, and withdrawing superseded copies. Implementing QMS on site.
  • Third party management; including supplier qualification and risk assessments, supplier quality audits, vendor qualification and vendor management.
  • Internal and external audit activities, and follow up on CAPAs, ensuring continuous improvement of systems and procedures.
  • Review and implementation of change controls, deviations, CAPAs etc.
  • Writing processes, preparation and review, as well as approval of area documentation (SOPs, work instructions), trainings, PQRs.
  • Preparation of content for internal quality review meetings, and delivering relevant presentations.
  • Liaising with different stakeholders for product artworks.
  • Management of complaint handling.
  • Batch release management.

 

Benefits

  • Attractive salary + superannuation.
  • Ongoing opportunities for learning and development.
  • Opportunity to grow your career with a fast-growing company.