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Quality Compliance Auditor

  • Location: Limerick, Limerick, Munster, Ireland
  • Job Type:Permanent

The Quality Compliance Auditor will conduct internal policy and procedure audits to ensure conformance with international quality system and Good Laboratory Practices standards, including leading SME teams, and establishing and executing auditing schedules.


Key Responsibilities:

  • Conduct audits including complex assessments, to ensure conformance with applicable regulations and policies and procedures. Assess objective evidence to determine conformity to requirements listed above, including ranking the levels of non-conformance findings

  • Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, allocate time, and schedule meetings. Assess previous audit findings to establish priorities and strategies

  • Develop audit process findings, and may have input to improve process flow for compliance, and evaluate the effectiveness of previous corrective actions

  • Provide input and may lead projects, based on understanding of international standards and regulations, to business unit and/or corporate quality initiatives including special projects, such as designing and/or recommending systems, procedures, etc

  • Evaluate the appropriateness and effectiveness of corrective actions

  • Provide training, guidance, and coaching to team members

  • Execute audit considering scope to assure efficient and effective use of scheduled time allocations

  • Assist in generating metrics for overall auditing system and identify continuous improvement opportunities; may also present metrics to all level of the organization

  • Assist in Regulatory Audits Lead efforts to prepare the site for Regulatory Audits. Provide training on audit best practices. Act as Internal Auditor SME

  • Other duties assigned by Leadership.

Education and Experience:

  • Bachelor's Degree in related field, 5 Years years experience Quality Compliance Auditing Required and

  • Pharmaceutical or Medical Device industrial experience preferred

  • Certification and experience in Professional Audit Designation required

  • Full knowledge of ISO13485/QSR/MDSAP

  • Ability to manage multiple concurrent audits.

For a confidential discussion and more information on the role, please contact Barry O'Brien  

barry.obrien@collinsmcnicholas.ie

021-4911060