about 1 month ago
Hamlyn Williams are working with a top tier global biotech company located in Buckinghamshire who are going through an exponential phase of growth due to such a successful pipeline. As a result of such growth, they are looking for a GCP/GxP QA manager on a permanent basis.
This role will involve leading a team of auditors on-site as well as 30% of travel abroad to affiliate sites-mainly Europe.
Responsibilities include but is not limited to:
• To assist in preparing a risk-based, global annual GxP audit plan for the company.
• To plan, arrange and lead GPVP and GCP audits of the company’s Global PV systems, affiliates, partner companies, suppliers and CROs.
• To participate in and assist with other GxP audits, assigned from time to time
To follow up and review/approve post-audit CAPAs and actions.
To ensure that the correct risk level is identified for each audited site and that GxP compliance risk is escalated through the right channels, to the right people in the least time.
To collaborate with the UK&EI QPPV, EEA QPPV and Head of Global Pharmacovigilance to develop an acceptable GPVP audit strategy
To support the Global GxP Audit function in compiling and maintaining a risk-based, five-year rolling plan of scheduled and completed audits.
• To support GPVP inspections in the UK or affiliate sites
If you have GCP audit/inspection experience, then reach out for a confidential conversation on this opportunity.