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Quality Assurance (QA) Auditor
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Description
Quality Assurance (QA) Auditor
Ref: NJ 13648
This is an exciting opportunity and a key CQA role for an experienced GCP Auditor to participate in audits for global clinical trials across Europe. Our client is a world leading independent biotechnology company that discovers and develops important therapeutics, bringing meaningful improvement to the lives of people all over the world. They are seeking a QA Auditor to be based in one of the company’s European locations.
LOCATIONS: England – Cambridgeshire or Middlesex; Germany – Munich; Spain – Barcelona; Italy – Milan; Poland – Warsaw
JOB ROLE: The Quality Assurance Auditor will be part of the company’s global CQA team, based in an Affiliate Medical Department. He/she will report to the regional team manager in Paris and be fully integrated into the International CQA department.
KEY ACTIVITIES & RESPONSIBILITIES include:
• Planning, leading and participating in audits of the company’s clinical trials across Europe.
• Providing a wide range of compliance advice.
• May support regulatory inspections of clinical sites and Company premises.
• Conducting trial audits of all types, acting on compliance concerns and audit findings, as well as helping ensure global compliance consistency.
• Travel approximately 50% of the time, including internationally.
QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:
• Bachelors Degree in appropriate discipline or Nursing qualification.
• GCP Auditor experience is essential with good knowledge of basic auditing principles.
• A clear understanding of the principles and application of GCP and in-depth knowledge of local regulatory requirements.
• Knowledge and experience of the pharmaceutical industry
• Basic understanding of multiple domains of the Certified Information Systems Auditor or Certified Information Systems Security Professional or equivalent (EPQA)
• Fluent in English and the local language, both written and spoken.
BENEFITS OF THE ROLE: Our client is a global company that has been widely recognised as a top employer by various bodies and surveys. They offer an outstanding work environment with a culture based on a deep respect for individual talent and a value system which ensures that every person has the opportunity to make a significant difference. Career development opportunities are there for the taking, salaries are competitive to the local market and their comprehensive benefits which are tailored to requirements include: bonus, sign-on stock units, life insurance and a car or car allowance.
Fforde is a uniquely specialised recruitment agency/business for the pharmaceutical, clinical research and biotechnology sectors. For applications please email your CV to: nicky@fforde-management.com or speak to our specialist consultant, Nicky Quinn on +44 (0)1273 222968 who will be pleased to give you further information and advice on your personal career needs. Visit our website and see all our job opportunities at www.fforde-management.com
KEY WORDS: Quality Assurance Auditor, QA Auditor, GCP Auditor, Clinical Quality Assurance, CQA, Regulatory, Compliance, Certified Information Systems Auditor, EPQA, Cambridgeshire, Middlesex, Munich, Barcelona, Milan, Warsaw
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