AddressOperating as a Major global Multinational pharmaceutical manufacturer with global sites worldwide, our client is well known for its growth and innovation and is an Australian iconic brand in the marketplace.
Due to increase in project requirements, our client is now seeking a Senior QA Associate - Sterility to be responsible for validation and qualification of the facility, utility & equipment on site.
About the Opportunity
Key responsibilities include the following:
- Participate in Validation & qualification of the facility, utility & equipment, process, personnel & method at the site.
- Perform governance & trending of Environmental & Personnel monitoring, In-process testing and finished product testing.
- Provide expertise to the site related to Sterility Assurance standards ensuring systems are aligned with the Sterility Assurance function.
- Perform risk assessments and reports as required.
- Partner with Global & Local Quality Sterility Assurance teams to ensure the same principles & systems are applied across all sites.
The successful candidate will have the following skills & experience:
- Tertiary Qualifications in Science or Engineering.
- Sound knowledge of sterility assurance, Media fill concept, environmental monitoring, Aseptic filling, Contamination control.
- Specific Validation and qualification experience from QA, Environmental monitoring, media fills.
- Minimum of 3 to 5 years of pharmaceutical manufacturing industry with sterility assurance of aseptic processing.
- Experience in QA functions & interacting with regulatory authorities & the ability to Influence key stakeholders.
- Sound communication & interpersonal skills.
- Experience using Microsoft Word, Excel, Power Point.
This is an Excellent Long Term Contract Opportunity for Senior QA Associate with Sterility Assurance to join global pharmaceutical organisation for be involved in Sterility Assurance work with sites locally & globally.
How To Apply
To apply for this role, please click on the LINK button.
For confidential discussion, please contact Sue Campbell on 0417 994 *** or or Maria Julienne on 0491 694 ***.
PLEASE SUBMIT MS WORD DOCUMENTS ONLY
NB: Only shortlisted candidates will be contacted.
Additional information
- Global Pharmaceutical Manufacturing Organisation
- Excellent Long Term Contract Opportunity
- Melbourne Metropolitan Area
