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Hyper Recruitment Solutions are currently looking for an experienced Clinical QA Auditor to join a leading Pharmaceutical company based in the Cambridgeshire area. As the Clinical QA Auditor you will be responsible for ensuring continued GCP compliance across multiple therapeutic areas and departments.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical QA auditor will be varied however the key duties and responsibilities are as follows:
1. To assist the CQA manager with the planning and maintenance of a clinical audit schedule. This will involve generating effective audit plans, and collaborating with Clinical Project teams to ensure audits meet client regulatory requirements.
2. Perform investigator site audits and assess study data integrity.. You will ensure studies are conducted in accordance with study protocols which will ensure compliance with GCP and other regulatory guidelines. You will also audit or review and processes within the R&D function, successfully identifying any procedures that could threaten continued GCP compliance.
3. As the Clinical QA Auditor you will be responsible for generating effective audit reports in accordance to RQA guidelines, you will react to audit findings to implement effective CAPA's. You will produce audit certificates at the conclusion of any audits, manage risk investigations and track any associated CAPA's.
4. You will be responsible for providing GCP training to colleagues and external clients, as well as generating quality metrics for reports to management.
To be successful in your application to this exciting opportunity as the QA Auditor we are looking to identify the following on your profile and past history:
1. Proven industry experience in Quality Assurance, with extensive previous Auditing experience. A industry recognised lead auditor accreditation would be highly advantageous, along with the ability to audit Phase I-IV investigator and vendor facilities.
2. A working knowledge and practical experience with following GCP guidelines, with in depth knowledge of Clinical Trial related ICH guidelines.
Key Words: GMP | GDP | GCP | GXP | Auditor | QA | Quality Assurance | Lead Auditor | Pharmaceuticals | Science | SOP | QP | Quality | Internal | External | Supplier Audit | Compliance | MHRA | FDA | Inspection | CAPA | QMS | Documentation | Quality Management | ICH | Clinical Trials | Phase I | Phase II | Phase III | Phase IV | Drug Development |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.