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Quality Assurance Auditor

  • Job type: Permanent
  • Location: Estenfeld
  • Salary: -
  • Job reference: 8569
  • Sector: EPM Scientific, Quality
  • Date posted: 31/07/2017
Quality Assurance Auditor: 

-Performs internal/vendor audits, quality reviews, and gap analyses 
-Good Clinical Practices, and EN ISO 9001/ISO 13485 and applicable regulatory requirements
-Effectiveness of vendor Quality Management Systems
-Identification of potential/realized risks
-determination of systemic approaches to effectively correct and prevent issues from recurring through utilization of risk based and control concepts
-Manages multiple QA tasks in parallel and effectively 
-Effective time management, tracking deliverable and when necessary, escalations to supervisor
-Acts in leadership role for joint department/vendor auditing efforts with other QA Auditors

Qualification and Skills needed: 
 
-College Degree in Health/Life Sciences.
-5-7years experience in a Quality Assurance capacity with a focus on GCPs and previous auditing experience.  GMPs experience with medical devices is a plus.
-Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities.
-Excellent leadership, analytical, organizational and communication skills.
-Ability to write concise and accurate audit reports.
-Competent in Microsoft Office, especially spreadsheets, database and reporting tools. Experience with CAPA Management systems desired.
-Ability and willingness to travel at least 10-15% of the time (international and domestic).

If of interest please submit your CV to apply.a33ho1gh43r@epmscientific.aptrack.co.uk or call on 0044 203 873 2541

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