- We are recruiting an Inspection Readiness, Senior Specialist (Compliance) contract position to join an existing Quality team on site.
- 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.
Education & Qualifications Required:
- 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.
- 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.
- 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.
- 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
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.