AX-7276 Senior GxP Quality Auditor
As a Global GxP Quality Auditor you’ll be responsible for managing global GMP/GDP audits to ensure GxP compliance of systems, manufacturing processes and vendors, and ensuring the delivery of annual audit programs.
Global specialty-driven biotechnology group
Offer products in oncology and endocrinology amongst others
Launches anticipated over the next 2 years
Will involve circa 60% travel
- As a member of the Global Quality Audit team, the incumbent must ensure that audits are planned, conducted, followed up and managed in accordance with GQA and company procedures as part of a Quality Management System that allows the company to achieve a high standard of compliance with regulatory guidance
- 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 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.
- 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.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- A minimum of a bachelor’s degree is required
- Significant experience in conducting global pharmaceutical GMP and GDP audits with experience in Regulatory inspections management
- IRCA qualified
- Experience in auditing sterile manufacture
- Demonstrable in-depth knowledge of GPV requirements and regulations
- Willingness to travel up to 60%
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300 quoting reference 7276.
To apply, please click the APPLY ONLINE button.
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