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controlled copies, updating controlled document database, filing and archiving of controlled documents, and withdrawing superseded copies.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.
- Attractive salary + superannuation.
- Ongoing opportunities for learning and development.
- Opportunity to grow your career with a fast-growing company.