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Job Description

Senior GMP Auditor needed for bio-pharmaceutical company in Limerick. All talented candidates are welcome to apply. The Senior GMP Auditor is responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area..

Role of this position

  • Schedules, prepares, and conducts audits in support of GMP as directed.
  • Assembles and coordinates the activities of the audit team.
  • Conducts audits in accordance with Regeneron 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.
  • 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.

JOB REQUIREMENTS

  • BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry
  • 2-5 years of audit experience in GMP environment preferred.
  • This position requires 40% travel

Please call Mike Morrissey today for further information on 021-429 7536 or email: mmorrissey@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Manufacturing & Production

Engineering & Technical

Scientific & Laboratory

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