Quality Administrator
6 days ago
PERSOLKELLY have a great opportunity for the right person to to join a QA team as a Quality Assurance / Compliance Officer (QA Officer). Reporting to the Quality Manager, you will be responsible for reviewing and maintaining the quality system requirements for GMP compliance, that all procedures are followed and that products are made to the required standard.
**Compliance Officer - TGA experience**
PERSOLKELLY have a great opportunity for the right person to to join a QA team as a Quality Assurance / Compliance Officer (QA Officer). Reporting to the Quality Manager, you will be responsible for reviewing and maintaining the quality system requirements for GMP compliance, that all procedures are followed and that products are made to the required standard.
The ideal applicant will have experience in a similar role, and show evidence of implementing, managing, and maintaining Quality Systems and processes in alignment with organisational requirements.
**Advantages**
- Competitive remuneration
- A supportive and energetic team
- A positive and engaging employee experience
- Career Development
**Responsibilities of the QA /Compliance Officer**
Technical / Operational
- Management of the validation master plan and all related validations
- Develop and maintain Quality Systems and Procedures to ensure high product quality
- Coordinate and manage the stability program
- Assist in preparation of Product Quality Reviews
- Review CAPA's, CC, NCRs, PDRs and OOS
- Support in the maintenance of all regulatory licenses
- Assist in External and Internal Audits
- Assist in maintaining and implementation of stability studies
- Review and update documentation
- Identifying opportunities for improvement
Internal Systems and Processes
- Ensure all QA/QC activities are performed in accordance with the clients Quality policies
- Collaborate with Quality and Manufacturing staff to ensure quality procedures and processes are maintained and improved.
**Backgound**
Essential
- Degree in Science (Chemistry) or equivalent background
- Minimum of 5 years experience in QA/QC
- Knowledge and understanding of the TGA code of GMP
- Knowledge and understanding of the ACO (highly preferred)
Preferred
- Quality Assurance experience in the pharmaceutical industry
- Knowledge and understanding of the JAS
- Knowledge and understanding of the COSMOS
**Competencies**
Technical / Operational
- Good understanding of equipment, process, and cleaning validation
- Ability to monitor stability studies
- Ability to oversee GMP in the organisation
- Ability to utilize and implement BP and other compendial references
- Analysis of data / statistics
- Thorough understanding of UV/VIS spectroscopy and basic wet and dry chemical testing methodologies
- Trouble shooting of technical and system failures
- Computer literacy in Microsoft Office programs
- Ability to prepare accurate, clear, concise, and well-presented reports and procedures.
If you feel you are suitable for this role please apply.
Please note only successful applicants will be contacted.
QLD Licence
- LHL-02514-D2P2F
**Who are we**
At PERSOLKELLY, our passion is - and always has been - putting you first.
We propel our people forward by supporting their careers in fresh ways, backed by our expertise and capability.
We're committed to creating a safe and inclusive environment which values and respects diverse styles, backgrounds, experience and perspectives.
We welcome and encourage women, people of Aboriginal and Torres Strait Islander descent and people from diverse backgrounds to apply.
**So it's over to you. If you would like to join our team, please APPLY now.**
**To learn more about working with PERSOLKELLY, we encourage you to visit our website.
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