Senior Global GMP Compliance Manager
We are currently looking for a Senior Global GMP Compliance Manager to join a leading Biotechnology company based in the Berkshire area. As the Senior... View Job
Hyper Recruitment Solutions are currently looking for a QA Officer to join a leading Bio-Pharmaceutical company based in the Wiltshire area. As the QA... View Job
Qualified Person / QP
We are currently looking for a Qualified Person / QP to join a leading Pharmaceutical company based in the Buckinghamshire area. This exciting opportu... View Job
12 month fixed term contract
To support the organisation in the preparation activities for Competent Authority inspections, ensuring independent assessment of the ability to reconstruct activities undertaken during the conduct of clinical trials. Responsibilities: ·To assist the Clinical Quality Assurance (CQA) Operations Manager with the, implementation and conduct of the Clinical Delivery Charter and other relevant charters. ·To review documentation created to ensure that individual studies can be recreated as per ICH 8.1. ·To report noncompliance to the CQA Operations Manager and client groups where appropriate. ·To assist with the preparation for GCP inspections conducted by national and international regulatory authorities. ·To assist the CQA Operations Manager with the promotion of quality awareness among clinical investigator site personnel and assist with the development and maintenance of inspection awareness training, and provision of advice and guidance. ·To identify and communicate quality improvements in GxP activities as part of preparation follow-up (Lessons Learnt). ·To act as a QA specialist providing support to the Clinical Department as required providing advice on processes and audit references, according to applicable current regulations / guidelines. ·Executes additional tasks in order to meet departmental project-related or developmental/change objectives. · Requirements: ·A Bachelor's degree in a scientific discipline or nursing degree. ·Previous experience in the pharmaceutical industry within clinical research. ·ICH-GCP, international regulations and guidance, with the ability to apply this knowledge to resolve day-to-day issues. ·Understanding of GCP and Trial Master Files for Clinical Studies. ·Excellent attention to detail and the ability to identify the root cause of problems. ·Excellent investigative/analytical skills.