Quality Systems Specialist - Audits

Job Ref: J30605
Sector: Science
Sub-sector: Biotech/Life Sciences
Job Type: Permanent
Date Added: 29 April 2019
  • Birmingham, West Midlands, England, UK Birmingham West Midlands UK B15 1QT
  • Competitive
    ANNUM
  • Eleanor Gorton
  • 0121 728 8455
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Quality Systems Specialist - Audits

Are you experienced working with quality systems under ISO13485 and FDA regulations? Are you looking for the next move in your career where you will be able to influence the direction of a multinational biotechnology company that has shown continued growth over the past 5 years? My client is looking for a suitable qualified individual who has experience working on the quality system of medical device to join their QA team and are offering an attractive package.

Job Purpose:To conduct internal and supplier audits as Lead Auditor to meet regulatory requirements and follow up to ensure any deficiencies are appropriately addressed i.e. NCRs and CAPAsKnowledge and Skills

Essential:Biological or chemical based degree or equivalent.Qualified Lead Auditor.Training in FDA Quality System Requirements.Full understanding of ISO13485 / FDA QSR.CAPA Management.Audit planning, execution and follow-up.Able to manage multiple projects.Good problem-solving skills and attention to detail.Excellent communication skills - both verbal and written.

Desirable:Process and equipment validation training attendedJapanese Ordinance 69/ISO9001, Health Canada and CMDCAS requirements.Experience of research and development of biological and chemical based products.IVD DirectiveKnowledge of antibody/ antigen reactions.

To discuss this role and the company informally please call Ellie on 0121 7288458.

SRG
29/05/2019 12:58:10
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