Senior QA Auditor - 60% - 80%

3 мес. назад

United KingdomEuropeSeniorHybrid

analytical skillsproblem-solving

QA Auditor role focused on analytical and problem-solving skills to aid in drug discovery for rare diseases.

О компании

Do you want to use your strong analytical, problem-solving skills to help find treatments for rare disease patients? About is an AI-powered tech bio company that is redesigning drug discovery. With 10,000 rare diseases affecting 400 million people globally, 90% of which have no approved treatment, is on a mission to pioneer the next generation of drug discovery to help rare disease patients in need. We combine data, artificial intelligence and deep pharmacology expertise to develop treatments more quickly and cheaply than traditional drug discovery. Diversity and inclusion sits at the heart of our mission to help people with rare diseases, and we believe that attracting and empowering a diverse team is critical to achieving this goal. We welcome applications from people f

Обязанности

Review and co-approve Quality Technical Agreements with GMP vendors, and ensure any project study changes in scope are appropriately reflected 
Manage GMP documents, review and co-approve  batch records, and ensure proper control and archiving of quality-related data
Work closely with Regulatory Affairs to ensure that all manufacturing and clinical activities remain in strict alignment with current regulatory filings (e.g., IND, CTA, or MAA) and to support the preparation of regulatory submissions
Product Release: Approve or reject raw materials, intermediates, and finished products, often involving data review and certification. Verify that batch documentation and product specifications comply with the 'Approved' versions filed with Health Authorities before final certification or release
Investigations: Investigate out-of-specification (OOS) results, deviations, and trends, performing root cause analysis (RCA)
Include-Represent QA as needed for any product complaints and on the SPEC Committee
Work closely with 3rd party Production, R&D, QC, and Supply Chain teams and Regulatory Affairs teams to ensure chemistry, manufacturing, and control (CMC) compliance
Develop, write and maintain company SOPs in accordance with industry expectations, ICH-GCP and GMP guidelines and regulations where operates
Maintain and improve ’s Quality Management System (QMS), including delivery of training and tracking of training across company, change control (including regulatory impact assessment in coordination with Regulatory Affairs), deviations, CAPAs, and risk assessments, in cooperation with the management team (MT), department directors and with support from the Clinical Team
Prepare and execute the annual audit plan (scope to include compliance with QMS, external audits at investigational sites and third-party vendors) and in ensuring vendors maintain their qualification
Ensure is inspection ready at all times and conduct self-inspections and advise the Management Team and department directors on vendor selection and evaluation process
Liaise with Regulatory Affairs as the primary point of contact for official Health Authority inspections (e.g., MHRA, FDA, EMA), ensuring coordinated communication and timely submission of responses to inspection findings
Manage and oversee third party auditors to ensure compliance with ’s audit standards and current guidelines 
Assist in the preparation, management, hosting and follow-up of audits/inspections by third parties
Provide recommendations for corrective and preventive actions (CAPAs) resulting from audits and provide advice on the resolution of any other quality-related issues, escalations
Assist the Clinical team in preparing a project-specific Risk Management Plan.
Assist the Clinical team in preparing risk-based monitoring plans
Train personnel on Risk Management as appropriate

Требования

Bachelor’s degree in Science, Life Science or Health related field, or in Quality Management
Deep understanding of ICH-GCP and GMP guidelines, working knowledge of applicable EU directives/regulations, UK legislation and international clinical trial regulations (e.g., EU GMP, US FDA cGMP)
Strong analytical, problem-solving, and decision-making abilities
Process oriented and pragmatic
Excellent communication and interpersonal skills for leading teams and stakeholders
Willingness to travel to the US (once or twice a year)
Hands-on and collaborative approach to strong analytical, problem-solving
Interest in biotech/ techbio and its impact of improving patient outcomes 
Experience with electronic Quality Management Systems (eQMS)
Ability to work in cleanroom environments and experience of conducting GMP audits

Другое

Have successfully managed the interface between Quality and Regulatory Affairs, specifically regarding the regulatory impact of manufacturing changes and clinical trial amendments
Have ensured that audit results are monitored for trends and advise the Leadership Team, and staff, on improvements
Sucessfully assisted the Leadership Team in preparing and maintaining a corporate Risk Management Plan (RMP)
Have translated guidelines, rules and regulations into clear and usable recommendations / procedures