Quality Excellence Specialist
Posted 5 days ago by Hyper Recruitment Solutions
Negotiable
Undetermined
Undetermined
London, England, United Kingdom
Summary: The Quality Assurance Contractor (GxP) role involves ensuring inspection readiness and quality oversight in early drug development and clinical studies for a leading pharmaceutical company in Greater London. The position requires leading QA oversight, performing audits, and managing compliance with GLP/GCP/GMP/GRP regulations. The contractor will also oversee data integrity in research submissions and provide QA support for global submissions. Candidates should possess a relevant scientific degree and extensive experience in Quality Assurance within the pharmaceutical or biotech sectors.
Key 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.
Key Skills:
- 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.
Salary (Rate): undetermined
City: London
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Role Overview 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 Your duties as the Quality Assurance Contractor (GxP) will be varied however the key duties and responsibilities are as follows:
- 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 To be successful in your application to this exciting role as the Quality Assurance Contractor (GxP) we are looking to identify the following on your profile and past history:
- 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.
Key Words Quality Assurance / GxP / GLP / GCP / GMP / GRP / pharmaceutical / biotech / clinical studies / regulatory compliance / inspection readiness / CAPA / bioanalysis / gene therapy
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.