Regulatory Compliance Associate
5 days ago
About the Opportunity
We are seeking a skilled Regulatory Compliance Associate to join our team in Melbourne. The successful candidate will be responsible for ensuring the quality of our mRNA drug substances produced at our facility.
Your key responsibilities will include:
- Providing guidance on regulatory compliance and Good Manufacturing Practices.
- Developing and implementing processes to ensure regulatory compliance.
- Conducting audits and inspections to ensure compliance with regulations.
- Collaborating with cross-functional teams to resolve regulatory-related issues.
You will also be responsible for:
- Reviewing and approving documentation and records to ensure regulatory compliance.
- Maintaining knowledge of regulatory requirements and updates.
- Providing training on regulatory compliance and Good Manufacturing Practices.
- Contributing to process improvements to enhance operational efficiency.
The Ideal Candidate
To succeed in this role, you should possess:
- A Bachelor's Degree in a science field or equivalent combination of education and experience.
- Minimum 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.
- Knowledge and use of electronic systems, including SAP, LIMS, and MODA, for batch release, deviations, lab data management, and manufacturing execution.
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