- Reference: GY45127
- Job Type: Permanent
- Location: Limerick
- Category: Bio-Pharmaceutical
My client who has been consistently ranked aTop Employer in Science Magazine’s rankings for pharmaceutical and biotechnology companies is looking for exceptional people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.
As GMP Auditor you will be responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area.
- 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 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.
- Assists with training/orientation for new Quality Auditing staff.
- Supervises junior auditors.
Please note that this position requires 40% travel.
Skills, Experience and Qualifications needed for this role:
- BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry, 2-5 years of audit experience in GMP environment preferred. Other relevant experience may be considered in lieu of degree.