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.
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