My client is a rapidly growing specialist Contract Research Organization. A world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. They have an an impressive portfolio of 11 human challenge models, with new models under development, providing provide end-to end early clinical development services to their established and ever-growing client base which include four of the top ten largest names in the global biopharmaceutical industry. This business is looking for a Senior QA Auditor (GCP) to join their site in London on a permanent basis.
Key Responsibilities:
The main responsibility of the Senior QA Auditor is to ensure that the site is in compliance with relevant SOPs, regulations and internationally recognized guidelines (Statutory Instrument 2004 No. 1031 and its amendments, ICH GCP and GCP for Laboratories).
• Plan and conduct assigned internal audits of processes, systems, facilities, studies and documents including protocols, reports, and computer system validation documents in line with the annual audit programme and appropriate study audit plans to verify compliance and determine the effectiveness of the company’s quality systems and procedures with agreed timescales.
• Follow up and close out all assigned audits including agreement of appropriateness of corrective actions to audit findings with relevant staff.
• Assess compliance with the Quality Management System (QMS) and ensure appropriate actions are agreed and effectively followed up.
• Maintain an up-to-date knowledge of the current regulations, guidelines and company SOPs.
• Plan for audit by review of previous audit reports and relevant legislation and guidance.
• Produce audit plan where relevant to detail scope of the audit.
• Conduct allocated process, system, facility, study, document and data audits by review of relevant documentation, observing relevant procedures and tours.
• Assess compliance of the process, system, facility, study or document and categorise audit findings appropriately.
• Conduct audit close out meetings to present findings to relevant staff.
• Produce audit report detailing audit summary, scope and findings and present for peer review;
• Conduct peer reviews of colleague’s audit reports to ensure accuracy and appropriateness of findings and classification of findings.
• Follow up of audit response not received within assigned timeframe.
• Assess audit responses for appropriateness of corrective and preventive actions and advise auditee on appropriate responses until agreement is reached.
• Conduct QA review of SOPs and associated Master Forms as part of review and approval system.
• Plan, conduct and follow up audits across all business areas within the organization and all audit types and document types (laboratories, clinical, data management, computer system validation).
Required Qualifications:
• Bachelor's or Master's degree in relevant Science-related discipline.
• 2-3 years' experience in GCP or QA in a pharmaceutical organization or CRO.
• Knowledge of GCP and GCP for Laboratories regulatory standards.
• Proven knowledge of drug development process.
• Working knowledge of GLP and GMP standards.
• Excellent attention to detail
• Proven communication skills and ability to work cross-functionally across all levels.
Apply now or contact Anita at +441293908123 or email aosibuamhe@barringtonjames.com for a confidential conversation today
