Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organization headquartered in the United States with offices in Ireland, UK, Switzerland, Italy, Singapore and China. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. We provide services in the areas of quality, compliance and regulatory; automation, commissioning, and qualification; validation, maintenance, and reliability; building commissioning, consulting, and information management systems.
Meeting a Higher Standard
As 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 (our core values). That is how we have grown exponentially.
Job Requirements & Responsibilities
· 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.