Quality Assurance Associate

5 days ago

Melbourne, Australia PERSOLKELLY Full time

Our client, leading research-based biopharmaceutical company, is seeking a Quality Assurance Associate to join their team in Melbourne.

**Your responsibilities will include**:

- Administrate the activities for change request management (assessment, implementation, and tracking).
- Administrate the activities for documentation management (revision, verification, approval, and storage/archiving).
- Support local functions in the requirements and use of the Change Control and Documentation systems.
- Assure Company practices meet TGA, FDA, MHRA, EMA, Health Canada, cGMP and other regulations.
- Support project requirements for master data build as required.
- Adhere to compliance plans aligned with company objectives both local and global and support local functions in achieving requirements.
- Prepare regular reports on department performance and quality metrics.

**Other Position Requirements include**
- Tertiary Qualifications in Engineering, Scientific or related discipline is required for this role
- Proven experience in quality management, pharmaceuticals and/or regulated environments.
- Experience within a Laboratory or Production/Manufacturing environment is desirable.
- Knowledge of cGMP, GLP and Regulatory requirements for Australia, EMEA and USA.
- Work prioritization skills
- Experience in a Microbiology environmental monitoring programme
- Ability to keep comprehensive and accurate records in a multi-faceted environment
- Well-developed written and verbal communication skills
- Well-developed consultation and negotiation skills
- Proficient computer literacy

**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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