Entrust People are recruiting on behalf of one of their clients, a leading global pharmaceutical corporation, with a multi-billion dollar turnover and an international reputation for quality and innovation.
We have a very exciting opportunity for a Quality Auditor to join the business. Please note this role can be based at either our Basingstoke or Liverpool site.
Responsible for the quality audits in R&D clinical (GCP), non-clinical (GLP), Regulatory Affairs (RA) and/or Pharmacovigilance (PV) areas to ensure systems, procedures and resources are in place for effective implementation of the Lilly Quality Standards (LQS) and the Quality Standards (EQS). The scope of this role covers R&D, RA and PV audit activities
Some of your Key Responsibilities will include:
1. Plan, coordinate, manage, support and/or lead audits according to the approved EGQCA audit plan in R&D, RA and PV areas in accordance with EGQCA audit programs, strategy and priorities.
2. Apply a risk-based audit approach for the identification of audit targets with the objective to optimize value, time and resources while minimizing business risks.
3. Perform quality assessments such as due diligence and/or pre-qualifications of Contract Research Organization (CRO), investigator sites, laboratories, third parties and suppliers for GCP, GLP, RA and/or PV activities.
4. Conduct routine systems audits of affiliates and R&D sites, directed/for cause audits of focused specialized areas, mock audits (as part of the regulatory inspection readiness, preparation for pre-submission/pre-approval inspections) according to the requirements laid down in the relevant LQS/ EQS and the site specific Standard Operating Procedures (SOP) .
5. Prepare and issue quality assessments and/or audit reports; assess adequacy of the auditee’s responses to audit observations/findings and approve Corrective Action and Preventive Action (CAPA) plan.
6. Ensure appropriate notification to management in case of critical observation/finding and support immediate follow-up measures according to EQS.
7. Act as Subject Matter Expert (SME), as assigned by EGQCA management by providing sound guidance to associates, customers and management, where appropriate.
8. Support in the preparation of regulatory authority inspections to ensure affiliates/sites are prepared and supported for any regulatory inspection readiness.
9. Ensure proper management, follow-up and closure of audits as well as regular monthly reporting of key quality indicators (KQIs) associated with audits, tracking and completion of CAPAs in TrackWise (TW138) audit database.
10. Communicate and liaise with internal and external stakeholders to drive quality mindset
· +5 years of clinical/industry/health authority experience in regulated industry;
· +5 years Quality Assurance auditing experience
· Technical knowledge in Pharmacovigilance
· Experience in Regulatory Affairs
· Knowledge of Compliance and Industry Standards in GCP, GLP and PV.
· Technical knowledge of preclinical and/or clinical drug development
· Excellent negotiation and interpersonal skills
· Ability to communicate effectively (written & verbal)
· Flexibility to work additional hours, as needed
· Ability to undertake local, interstate & international business travels.
· Fluency in English is essential.
· Knowledge of other languages applicable to the region.
· Bachelor degree in Science (agriculture, biology or chemistry) or related field (e.g. veterinary); (or equivalent experience)
Please note this role can be based at either the Basingstoke or Liverpool location.