A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a GxP Auditor. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in the company's UK office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
- Responsible for maintenance of the Global Quality audit schedule for audits within scope of this GxP role to ensure completion and adherence to the schedule.
- Responsible for independently leading, planning, conducting and reporting of routine audits in accordance with the approved schedule.
- Responsible for on time delivery of audit reports and review of CAPA plans in accordance with internal timelines.
- Responsible for updating the audit database to assist the manager and team with resource planning and KPIs
- In collaboration with GQA Director and other team members ensures delivery of the agreed annual audit program.
- Maintain the audit database and electronic audit systems for audits assigned as responsible person. Assist the GQA Director and team with resource planning and KPIs
- Maintains oversight of audits conducted by GxP contractors by assisting them with audit plans, review audit reports and maintain responsibility for report issue to stakeholders and auditees.
- Assists the GQA team by conducting peer review of audit reports conducted by other team members as required
- Responsible for managing audit travel and obtaining appropriate travel documentation as required to perform international audits.
- Responsible for review and approval of CAPA plans and in collaboration with stakeholder's review progress and advises and support the sites in devising and executing remediation actions to ensure compliance to regulatory and Global Quality expectations and requirements.
- Collaborate with the team to design and enhance the quality management system, including the ongoing development of SOPs, audit supporting tools, checklists, guides and reports.
- In collaboration with GQA director manages requests for non-routine audits and executes as required; this may include Due Diligence, for cause audits, cross-functional, complex/sensitive system/vendor audits as defined by the scope.
- Participate in the continuous improvement and maintenance of a global GxP compliance platform for reporting, reviewing and trending Global Quality Audit KPIs.
- Contribute to team reporting requirements as required by providing Quality Director with relevant KPI information.
- Advise, guide and support sites in the overall regulatory inspection management (preapproval inspections, general GxP inspections) covering inspection preparations,
- execution of regulatory inspections, preparation of responses to health authorities and inspection follow-up as well as for key customer audits.
- Participates in regulatory inspections in core and supporting roles. Assists with the preparation and delivery of training materials. Advises and contributes to coaching.
- Acts as Subject Matter Expert / Point of Contact to provide expertise and knowledge to less experienced auditors, Business Partners and company entities on quality and compliance processes/procedures.
- Interprets and applies regulations/ policies to issues of moderate complexity, when required.
- Participate in enhancing and maintaining a global platform for sharing Regulatory Inspection Deficiencies and "lessons learned" as well as significant customer audit observations to ensure such information is communicated tracked and responded to accordingly by all GMP sites.
Skills and Requirements:
- A minimum of a bachelor's degree is required, though a Master's degree in a scientific or health-related field is preferred.
- 10 Years of Quality Assurance / Quality Systems experience in a GxP environment.
- 5 Years of Experience in Regulatory inspections management.
- Fluent in English (verbal and writing).
- 5 Years of Quality auditing experience.
- In depth knowledge of GDP, GMP.
- 2 years of International travel preferred.
- Working knowledge of PV, Medical Device and Food Supplement requirements preferred.
- Experience of audits in all GxP is ideal.
- Experience in auditing sterile manufacture is ideal.
- Experience in microbiology is ideal.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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