Job Description
Qualified Person (QP) sought to certify medicinal products and provide quality guidance in a dynamic and growing company.
About CAI:
CAI is a 100% employee-owned company established in 1996, with a global presence of nearly 850 people. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Our approach is centered around putting the client's interests first, ensuring that every task is completed to the highest standard, and taking ownership of our work to achieve exceptional results.
As employee-owners, we live by our Foundational Principles, which include:
- We act with integrity.
- We serve each other.
- We serve society.
- We work for our future.
Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services. We invest in our employees' future, providing hands-on certifications and professional training to support their growth and development.
Requirements:
We are seeking a Qualified Person (QP) to join our operations in Ireland. The role of a QP in CAI is to:
- Certify medicinal products in accordance with requirements of product marketing authorisation, EU Directives, EU Annex 16 and Annex 13 where applicable for Investigational Medicinal Products.
- Provide quality and compliance guidance on critical and major quality matters.
- Provide quality direction and guidance for projects related to processes, product and compliance.
- Provide quality oversight of quality management system, procedures, release and compliance documents including CAPAs, Deviation Management, Change Controls and Quality Agreements.
- Ensure all necessary manufacturing, packaging and associated documentation has been completed and endorsed by suitably authorized staff.
- Ensure independence of the QP on decisions on quality related matters.
- Provide support with investigations and resolution of discrepancies.
- Provide audit support as required for client Health Authority Inspections, internal auditing program and supplier audits.
- Support client in continuous improvement initiatives for GMP compliance.
- Participate in cross functional teams to provide consultative support on quality related issues.
- Maintain an up-to-date knowledge of pharmaceutical legislation and industry practice.
- Support Quality/Compliance/Regulatory (QCR) business area lead with the achievement of Objectives and Key Results (OKRs).
Position Requirements:
- Third level qualification in a science related discipline.
- Eligible and demonstrated ability to act as Qualified Person within EC/EEA.
- Minimum 3 to 5 years QP experience.
- Excellent communication skills, including written, interpersonal, collaboration, and negotiation skills, with a team-oriented approach.
- Extensive demonstrated pharmaceutical quality experience.
- Thorough knowledge of biopharmaceutical and/or pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements.
- Audit experience would be beneficial.
- Strong task management skills with the ability to prioritise, schedule, and control under tight deadlines.
Salary: €80,000 - €100,000 per year
We are an equal opportunity employer, proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.