Inspection Readiness Specialist

Orion Group Life Sciences are currently recruiting an Inspection Readiness Specialist on behalf of our Multinational Biopharmaceutical client based in Dunboyne on an initial 11-month contract (with potential to extend).

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.

Experience, Knowledge, Skills, Qualifications:

• 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.
• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or in a relevant discipline

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.