Global Systems Auditor
A leading speciality pharmaceutical organisation is advertising a vacancy for a Global Systems Auditor, based in their office in the UK. The company specialises in the design and manufacture of state-of-the-art medical devices and prides itself on its large portfolio of products.
- Plan, prepare , conduct, report, and follow-up of system audits on a global level and for any of the processes owned by Research and Development, Medical Affairs and Pharmacovigilance, Clinical Sciences, and other interfacing departments within and outside of Pharma and Consumer Health e.g. Sales, Marketing, Product Supply).
- Plan the budget and resources needed.
- Travel and visit company sites on a worldwide basis.
- Develop all relevant tools necessary for the collection of audit data in line with the approved audit plans.
- Communicate system audit results (incl. identification of process improvement opportunities and proposed actions) to all relevant personnel.
- Lead and drive audit activities, such as trending activities regarding to Pharmacovigilance, Regulatory, and other GxP activities.
- Support Regulatory authority inspection activities as needed with focus on Pharmacovigilance and Regulatory topics.
Skills and Requirements:
- BS in a biomedical science, or equivalent education, with at least 7 years of pharmaceutical industry experience, or a MS in a biomedical science, or equivalent education, with at least 5 years of pharmaceutical industry experience.
- Minimum of 4 years of product development related activities and a 2 year proven record in Research & Development auditing activities.
- Ability to assimilate large amounts of data efficiently, exercise sound judgement, and maintain composure to effectively handle sensitive issues, such as instances of serious process non-compliance.
- Willingness to travel up to 40%.
- Previous experience with tasks assigned to lead auditors in system audits (e.g. development of standards and tools, conduct, reporting and follow-up of system audits).
- Knowledge and experience in the application of requirements relevant to the audited processes (e.g. FDA, ICH, EU-GVP) as well as familiarity with the essential documents related to those processes.
- Familiarity with medical terminology, routine medical tests and procedures, computer systems used in the relevant areas and use of computerized databases.
- 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.
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.
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