QP - Qualified Person

About CAI:

CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 850 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.

Meeting a Higher Standard:

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.

With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.

CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.

Requirements include:

We are now seeking a Qualified Person (QP) to join our growing operations in Ireland. The role of a QP in CAI is to:

· The Qualified Person is responsible for certifying 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 (Corrective and Preventive Action), 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 (Qualified Person) 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

· Supporting Quality / Compliance / Regulatory (QCR) CAI business area lead (BAL) with the achievement of Objectives and Key Results (OKRs).

· 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

· Must have excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team-oriented approach.

· Extensive demonstrated pharmaceutical quality experience.

· Must have 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.

· Must have strong task management skills with the ability to prioritise, schedule, and control under tight deadlines.

We are an equal opportunity employer; we are 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. This job description is not all inclusive and you may be asked to do other duties.