Our client is a global pharmaceutical organisation with a highly recognisable brand in the international and local marketplace.
Due to an exciting new project, an outstanding opportunity for a mid-level experience QA Associate has arisen. We are seeking applications from candidates with proven experience working in a QA role within a medical device manufacturing environment.
This opportunity starts off as a 12-month contract, with the possibility of transitioning to a permanent role.
Duties include but are not limited to:
- Compose, update, and maintain SOPs and other QA documents
- Carrying out documentation activities such as GMP docs, quality manuals, DHFs, risk assessments, and batch records
- Validation activities for processes and equipment
- Carrying out investigations, and implementing CAPAs
- Collect, process, and analyse QA and QC data, and carry-out product approval releases
- Participate in risk management, conducting internal audits, facilitate third party audits, and assist in hosting external audits
The Successful Candidate will possess:
- Tertiary qualification in science or engineering (or related)
- Minimum 3 years experience in a similar role within the medical device industry
- In-depth understanding of ISO 13485 and cGMP, along with TGA, FDA, Health Canada, and other relevant regulations
- Proven experience developing, maintaining and updating QA documentation
- Analytical mindset, high attention to detail
- Excellent communication skills - Both written and verbal
If this role sounds like you, then please apply with your CV and cover letter in WORD format.
Questions can be directed to Leah Creswick at Fuse Recruitment on 0478 193 170.