Inspection Readiness Specialist (Hybrid)

Summary:
An Inspection Readiness Specialist is required for a biopharmaceutical company in Dunboyne.

Responsibilities:

• Support the implementation of the Inspection Readiness activities 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.
• Support internal audits (facility, system and walkthrough) in addition to supporting management of the internal audit schedule at the site.
• 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.

Qualifications & Experience:

• Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline.
• This role requires a seasoned QA Specialist with a minimum of 4 years’ experience in a similar related role in the Biopharmaceutical industry.
• A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant GMPs, regulations and current industry trends.
• At least 2 years’ experience in supporting Inspection Readiness Programs/ 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.
• The successful candidate will also ideally have a proven track record in delivering excellence.