▷ [Immediate Start] Quality Excellence Specialist

3 weeks ago


Bunbury, Australia ONE NUCLEUS Full time

We are currently looking for a Quality Assurance Contractor (GxP) to join a leading pharmaceutical company based in the Greater London area. As the Quality Assurance Contractor (GxP) you will be responsible for inspection readiness and quality oversight across early drug development and clinical studies.

Key Duties and Responsibilities:

- Lead QA oversight of early development and clinical studies, ensuring GLP/GCP/GMP/GRP compliance.
- Perform audits of study protocols, bioanalysis reports (PK, ADA), formulation/gene therapy studies, and associated documentation.
- Review and manage CSV, deviations, and CAPAs to support regulatory expectations.
- Oversee data integrity in research IND submissions, providing QA sign-off and support for global submissions.

Role Requirements:

- Relevant degree in a scientific discipline.
- Extensive industry experience in Quality Assurance within pharmaceutical, CRO, or biotech settings.
- A working knowledge and practical experience with GLP/GCP/GMP/GRP regulations and inspection readiness requirements.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.

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