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Senior Quality Auditor - Biopharma

Job Seekers Ireland Engineering, Science Pharmaceutical

Job Summary

  • Limerick
  • Permanent
  • BBBH767279
  • Sep 29, 2020
  • Competitive
Job Description

Senior Quality Auditor opportunity for a leading Biotech company

I am currently working with a leading biotechnology company that invents life-transforming medicines for people with serious diseases. This company are going through huge expansion at the moment and are on the lookout for a Quality Auditor to join their team on a Permanent basis.

This individual will be responsible for planning and conducting quality audits in a GMP manufacturing setting. The travel aspect of this role is on hold for now but there may be a requirement for up to 50% travel on occasions in the future.

Essential Duties and Responsibilities:

  • Schedules, prepares, and conducts audits in support of GMP.
  • Assembles and coordinates the activities of the audit team.
  • Conducts audits in accordance with the company's standard operating procedures and quality policies.
  • Interprets policies, standards, and regulations, and then evaluates potentially critical problems not covered by the policies, standards, and regulations.
  • Compile inspection reports to include findings, corrections and process improvements.
  • Track corrective actions and planned action agreements from inspections to closure.
  • Participate in continuous evaluation and improvement of all quality aspects at the manufacturing site with particular emphasis on process systems and QMS.
  • Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance.
  • Escalates any compliance issues.
  • Communicates audit results to management and auditees through written audit reports.
  • Manages post-audit activities and follows up on any necessary corrective and preventive actions by resolving any conflicts.
  • Assists with hosting regulatory facility inspections by acting as a scribe and/or document reviewer.
  • Drafts and issues periodic reports to site management as requested.
  • Assists with training/orientation for new Quality Auditing staff and supervises junior auditors.

Education and Experience:

  • BSc with 2-5+ years of related experience in Biotech/Pharmaceutical industry
  • 2-5 years of audit experience in GMP environment preferred.
  • Solid understanding of Quality Management Systems
  • Solid understanding of pharmaceutical/biopharmaceutical processes

If you would like more information, or would like to be considered for this role, get in touch with Kellie today on kodonovan@morganmckinley.com or 021 2300 300

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

kellie-o-donovan
Kellie O'Donovan
  • Consultant | Engineering Recruitment - Quality & Validation
  • 353 (0) 21 2300300
  • kodonovan@morganmckinley.com