Trainee Internal Gcp Auditor
2 weeks ago
Overview:
hVIVO are currently seeking a Trainee Internal GCP Auditor to work from our main offices in London, E1.
The Trainee Internal GCP Auditor will conduct audits of company processes, systems, facilities, studies and documents including computer system validation documents to ensure compliance throughout the company.
They will provide flexible administrative support to the QA Department in order to ensure GCP compliance. Support with CAPA investigations, eQMS (electronic quality document management system) and archiving activities as required.
Main Responsibilities:
- Under supervision, plan, conduct and follow up internal process, system, facility, study and document audits and external supplier audits in line with the audit programme to verify compliance.
- Work cross functionally to follow up and close out audits including review/agreement of appropriateness of corrective actions to audit findings with relevant hVIVO staff.
- Identify and assess Quality Management System (QMS) non-compliances and ensure appropriate actions are agreed and effectively followed up.
- Support with CAPA investigations, and/or conduct CAPA investigations under supervision.
- Support QA team with eQMS (electronic quality document management system) SOP activities as required.
- Become familiar with and maintain an up-to-date knowledge of the current legislation.
- Ensure compliance of the quality management system documentation.
- Support with QA training delivery and organisation.
Skills & Experiences:
- GCP or GCP for laboratories experience
- Knowledge of drug development processes
- Working knowledge of GCP and GCP for laboratories regulatory standards
- Excellent attention to detail
- Degree in Science or equivalent
- Knowledge of GLP and GMP standards and Quality Assurance auditing experience would also be desireable
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