Senior GMP Auditor
Reference: | POR/A005544 |
Location: |
Limerick
|
Qualification: | Degree | Experience: | 2-3 Years |
Job Type: | Permanent | Salary: |
Not Disclosed |
Consistently ranked as a “Top Employer” in Science Magazine’s rankings for pharmaceutical and biotechnology companies, our client offers a unique, world-class opportunity for interested candidates. An outstanding Senior GMP Auditor is required who is excited by a start-up environment and recognizes the opportunities that this offers and wants to be challenged
Summary:Responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area.
Responsibilities
- 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.
***This position requires 40% travel***
The Person
- BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry
- 2-5 years of audit experience in GMP environment
If you would like further Information you can contact the recruiter directly:
Paula O'Reilly | Tel: +353 (0) 1 507 9265