Quality Support for Product Proliferation and Change Control Execution

Europe / Ireland  /  Europe/Ireland  /  Full Time

Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2020 your step-up year. Come and join a growing team of highly motivated and exceptionally skilled professionals.  CAI offers you control of your career, your professional development, your growth and path to success.
Commissioning Agents, Inc. (CAI) is a rapidly expanding professional services organisation headquartered in the United States with offices in Ireland, Netherlands, Italy, Puerto Rico, Singapore, China and Malaysia. We work in the pharmaceutical, biotechnology, medical device, nutritional and building commissioning industries to provide industry best practices to our clients. We work in the areas of automation, commissioning and qualification, validation, maintenance and reliability, building commissioning, consulting and information management systems.
Quality Support for Product Proliferation and Change Control Execution
No. Of Roles – 4
Minimum Qualification – Degree in Science or Engineering
Minimum experience – Minimum 1 year experience with change control processes either authoring, reviewing or approving change control records.  Strong knowledge of material control and SAP is required.  Experience with Trackwise as the IT system for management of change control is a plus.
Role – Assists with execution of change control activities for changes impacting pharmaceutical manufacturing sites.  Follows a detailed changes control strategy to assist in identifying materials listed in SAP and the change control IT system that are  affected by a change.  Helps Quality lead assess material control so the project Quality lead can ensure any required material control is carried forward in alignment with the change control plan.
Location: Work will be executed using an ‘External Quality Assurance’ Model, this is remote work associated with sites in Spain and East Coast US. Some travel may be required.
 In return for your skills and knowledge, CAI offers a wide range of benefits including:
·         Health insurance, company paid critical illness insurance, Life Insurance, PRSA contribution and more
·         Annual profit sharing
·         Paid time off
·         Continuing Professional Development and Education (internal and external)
·         Opportunity to work abroad if desired



(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • No Layoffs in Company History
  • Other Benefits Depending on Country