CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 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.
We are now seeking a Qualified Person (QP) to join our growing operations in Europe. The role of a QP in CAI is to:
· To ensure the QMS is maintained to corporate and international guidelines and changing regulatory guidelines
· To ensure that the site is audit ready
· To assure that all implemented procedures are followed on the site, according to each product requirements.
· To manage all quality activities for the products assigned.
· To promote the importance of high-quality levels and the importance of a continuous improvement culture in all core company activities.
· Approves quality related documentation (operational areas auxiliary documentation – e.g. Cleaning protocols)
· Reviewer of quality related documentation (generated by the operational areas - e.g.: Batch Production Records)
· Assesses and approves Major and minor Change controls and procedures
· Assesses and approves deviations; QA Specialist is equivalent to Group leader for purposes of deviation approval.
· Release of API, intermediates, and excipients (provided minimum training and experience levels have been achieved per site procedures)
· To release medicinal products, investigational medicinal products, Drug substances and excipients manufactured, in order to assure that current Good Manufacturing Practices and provisions of the marketing authorization/ product specification file are applied
· To ensure that the site manufacturers authorization (MIA) and Active Substance Register (ASR) are updated as required.
· To communicate regulatory requirements to the different areas of the company and Health Authorities as required
· Participate in cross functional investigations of deviations and change controls and advise on corrective actions and assist with their implementation as appropriate.
· Notify the Health Products Regulatory Authority (HPRA) of potential recall if a product issue is of sufficient magnitude to affect the quality/ safety or efficacy of the product
· Foster an environment of Continuous Quality Improvement by identifying and implementing practices to deliver, quality, efficiency and service level improvements.
· Act as key contact for medicinal products and investigational medicinal products regulatory inspections.
· BS or MS in a relevant science or engineering field, or equivalent
· 10+ years QP/Quality experience in the Pharma industry
· Excellent oral and written communication skills
· Excellent problem-solving skills
· Customer-service focused.
· Able to travel domestically and internationally if required.