**Job Description:**
A Senior Quality Professional is required to oversee the certification and batch release of clinical supplies. The role involves acting as a Responsible Person on a WDA for Pre-Approval Access, supporting Health Authority GMP/GDP inspections and audits across the supply chain, and advising stakeholders on quality issue management and process enhancement/compliance.
Key responsibilities include:
* Certification and batch release of clinical supplies
* Responsible Person on a WDA for Pre-Approval Access
* Support for Health Authority GMP/GDP inspections and audits
* Quality issue management and process enhancement/compliance
**Requirements:**
To be successful in this role, you will need:
* A degree in science, engineering, or a related discipline with 10 years' experience in a biopharmaceutical/pharmaceutical industry role
* Eligibility to act as Qualified Person on the Manufacturing/Importation Authorisation
* Previous experience as a Responsible Person on a WDA is preferred
* Strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes, and Quality Assurance principles