We are working with a global Pharmaceutical whom are recruiting for a PV International Auditor to join their team on a permanent basis. You can either be based in home counties in the UK or in Switzerland or the US.
Major Responsibilities and Accountabilities
*Perform and/or lead primarily PV audits of internal systems and external service providers/business partners.
*Perform all activities including audit preparation, conduct, presentation and timely reporting of audit findings, prepare a written audit report, and evaluation of corrective/preventative actions (CAPAs).
*Participate in and/or provide leadership to small audit team for PV/GCP systems audits.
*Participate in solving 'for cause' situations or complex quality issues.
*Assist Inspection Management Team in preparation for and during regulatory authority inspection which involve PV activities and perform mock inspections.
*Partner with other Pharma personnel including Drug Safety, Clinical Operations, Legal, Regulatory Affairs etc) regarding PV compliance issue.
*Provide training and/or education to PV functional areas and groups.
*Contribute to the development and revision of procedures related to PV and GCP auditing.
*Participate in Quality Risk Management Quality Area Teams (QATs) and advice QATs in areas of expertise.
Qualifications:
*Bachelors or higher education in a biomedical / scientific discipline with significant pharmaceutical/biotech industry experience.
*Experience in Quality Assurance / Compliance role in an international environment and/or in Drug Safety.
*Auditing experience in PV preferred.
Experience and/or Competencies Required
*Knowledge of pharmaceutical research and development, GCP, and pharmaceutical industry auditing/compliance activities required.
*Proven record of working with cross-functional teams with an international orientation.
*Working knowledge of international safety reporting activities/regulations.
*Analytical, problem solving and decision making skills in a complex, fast-paced, and changing environment.
*Strong communication skills; verbal, written and presentation.
*Ability to influence and negotiate effective solutions, solid social and interpersonal skills
*Excellent organization skills with an ability to effectively prioritize tasks.
*Computer proficiency
*In addition to English fluency, knowledge of another European and/or
Asian language is desirable.
Travel: <40% International and Domestic