13691 – Quality Auditor – Dublin Contractor

Purpose:

This role is a 10 month Fixed Term Contract.

Inspection Readiness, Senior Specialist (Compliance) contract position to join the existing Quality team on site.

Responsibilities:

• Support the implementation of the Inspection Readiness Program on-site.
• Support Compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as applicable Regulatory Requirements.
• Lead proactive evaluation of site compliance against emerging regulatory trends.
• Be an advocate of continuous improvement in the Quality Management Systems.
• Initiate and maintain Quality related metrics related to the Site Inspection Readiness program, ensuring effective communication and follow up of same.
• Lead and perform internal audits (facility, system and walkthrough) in addition to supporting management of the internal audit schedule at the site.
• Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.
• Support the preparation and hosting of Health Authority inspections and Divisional GMP Audits.
• Generate and report metrics / trends for program adherence to requirements and effectiveness.

Minimum Qualifications and Experience: 

• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.
• Must have at least 3 years’ experience in delivering Inspection Readiness Programs and Internal Audit programs in a pharma/biotech regulated environment. Experience working in a drug substance manufacturing environment is highly desirable.
• This role requires a seasoned QA Senior Specialist with a minimum of 8 years’ experience in a similar Compliance-related role in the Biopharmceutical industry.
• A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant GMPs, regulations and current industry trends.
• The motivation to be an inspiring member of a high performing team.
• Communication, decision making, people influencing, and project management skills will be important.
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• GMP Inspection Readiness & Audit experience in the Pharmaceutical industry
• Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues
• The desire to continuously learn, improve and develop