Job Description
Qualified Person (QP) responsible for certifying medicinal products, providing quality and compliance guidance, and ensuring independence in quality-related matters.
About CAI:
CAI is a 100% employee-owned company established in 1996 with over 850 people worldwide, providing commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness.
Our approach is built on putting the client's interests first, striving for excellence, and working collaboratively to achieve our goals.
As a company, we live by our Foundational Principles:
- 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 range of professional services.
Role and Responsibilities:
- Certify medicinal products in accordance with requirements of product marketing authorisation, EU Directives, EU Annex 16 and Annex 13.
- Provide quality and compliance guidance on critical and major quality matters.
- Provide quality direction and guidance for projects related to processes, product and compliance.
- Ensure independence in quality-related matters.
- Support investigations and resolution of discrepancies.
- Provide audit support 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 excellent written, interpersonal, collaboration, and negotiation skills.
- 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.
CAI is an equal opportunity employer, proud to employ veterans and promote a diverse culture in our workplace.