Job Description
Qualified Person (QP) to certify medicinal products in accordance with EU Directives and Annex 16, providing quality and compliance guidance on critical and major quality matters.
About CAI: CAI is a 100% employee-owned company established in 1996, providing 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 simple: we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there. As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
- We act with integrity.
- We serve each other.
- We serve society.
- We work for our future.
As a QP in CAI, you will be exposed to cutting-edge technologies in the advanced medicine space, working with recognized subject matter experts to bring lifesaving therapies to market. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Responsibilities:
- Certify medicinal products in accordance with EU Directives and Annex 16.
- 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 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) CAI business area lead (BAL) with the achievement of Objectives and Key Results (OKRs).
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, 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 prioritize, 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. 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.