
Senior GMP Compliance Specialist
6 days ago
Job Overview
The Senior GMP Compliance Specialist position is a key role in ensuring the quality and safety of medicinal products supplied to Australia. As a member of our team, you will be responsible for undertaking compliance verification and technical reviews of overseas manufacturing sites.
About the Role
This is an exciting opportunity to join our team as a Senior GMP Compliance Specialist. In this role, you will be working closely with international regulators to assess equivalency against Australian framework. You will also have the opportunity to initiate, establish, and maintain strong relationships with stakeholders and exercise high-level consultation skills.
Key Responsibilities
- Undertake desktop-based compliance verification/technical review of sterile and non-sterile medicine manufacturers.
- Liaise with international regulators and assess equivalency against Australian framework to establish and maintain inspection reliance.
- Initiate, establish, and maintain strong relationships with a broad range of stakeholders.
- Exercise high-level consultation skills to effectively liaise with sponsors, overseas regulators, and other teams within the organization.
Requirements
To be successful in this role, you will need to have excellent communication and interpersonal skills, as well as the ability to work independently and collaboratively as part of a team. You will also require a high level of analytical and problem-solving skills, as well as the ability to interpret complex legislation and technical guidance documents.
Benefits
We offer a competitive salary and benefits package, as well as opportunities for professional development and growth. If you are looking for a challenging and rewarding career, please apply today.
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