Principal Auditor - Quality
- BBBH788923 Jul 29, 2021 Competitive
I am currently seeking a principal auditor to join a growing quality team in the pharmaceutical sector on a permanent basis.
This person will independently organise and perform quality audits including supplier, corporate and third-party audits. This role is a mixture of remote and on-site work and will also require travel to sites in the US predominantly
- Degree in Science, engineering, technical or relevant discipline essential.
- 8 years' experience in working in pharmaceutical manufacturing or a QA or compliance environment.
- Experience in API, Medical device, Sterile, injectables or combined device products desirable.
- Experience in supplier and corporate auditing essential.
- Excellent knowledge of domestic and international regulations such as GMP, GLP and ICH guidelines related to pharmaceutical dosage devices.
- Extensive experience in audit areas such as API, Micro Lab, sterile drug product and Mock PAI.
- Ability to conduct audits independently of drug product or medical device.
- Must have flexibility to travel internationally when needed.
- Management of the auditing program including tracking audit responses and auditees CAPA completion and close out.
- Complete multiple supplier audits throughout the year and lead corporate audits for the company.
- Evaluation of quality systems and practices.
- Support the audit program by conducting internal and external audits by leading or supporting audit team.
- Organize and lead periodic audit review meetings.
- Partake in and support FDA inspections in line with regulatory authorities during inspections.
For more information on this role and a confidential discussion please contact Aoife O'Driscoll, QA, and Validation Specialist Recruitment Consultant @ Morgan McKinley 021 2300 300 / firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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+353 (0) 21 2300300