Senior GxP Quality Auditor - GMP / GDP

A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a Senior GxP Quality Auditor - GMP/GDP. 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.

Job Responsibilities:

• 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, and 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.
• Interpret and apply 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.
• Collaborates cross functionally with key stakeholders to maintain agility in the audit program and to enhance the quality system.
• Maintains and completes training requirements in a timely manner to ensure inspection readiness at all times.
• Responsible for ongoing maintenance of personal training records
• Maintains current awareness of the regulatory and pharmaceutical industry environment and, as a result, can influence internal Business Partners and stakeholders on best quality & compliance practices to enhance the quality mindset.
• Participates and contributes to team meetings as required by the line manager and other team members.

Skills and Requirements:

• 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.

To Apply:

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 Katty Maia at +44 2038543317 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.

#LI-KB1

#Compliance/Quality