Our Clients are looking for us to fill some exciting, challenging and rewarding positions. Why not make 2021 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.
QA Validation Consultant
• Experienced in QA Validation activities
• Execution of cleaning validation protocols.
• Experience on writing and approving Deviations/ GMP documents
• Technical writing experience in writing site reports.
Essential Duties and Responsibilities include, but are not limited to, the following:
· Taking Cleaning Validation/ hold samples alongside Upstream/Downstream processing.
· Working closely with manufacturing to ensure the CIP/SIP and clean holds are to the correct times and samples are taken.
· Shows focus & a consistence approach to the role and tasks.
· Excellent people skills
· Experience in aseptic technique
· Experience in Gowning for IOS7/ISO8
· Generating and Executing Validation Protocols.
· Actively look for Continuous improvements
· Experience in Validation specifically cleaning validation and clean hold
· Experience in assessment of cleaning issues during study runs,
· Experienced Technical writer,
· Experience in Deviation/Change control writing,
· Capable of managing a large program, so project management skills would be necessary,
· An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works
· Experienced in coverage testing
· Generate/review/Approval of CV protocols,
· Generate Reports
· Maintain and update Cleaning Validation Plan
· Schedule of cleaning activities with Manufacturing
· Liaise with numerous departments
· Ensure Training is maintained and current.
· Follow all EHS/Safety SOP/Policies
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