Cleaning Validation Specialist In Ireland
2 semanas atrás
About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm founded in ****, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. 'Take your Career to a new Level' PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Cleaning Validation Executor Role Responsibilities: Taking Cleaning Validation samples alongside Upstream/Downstream processing. Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken. Shows focus & a consistent 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. 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. Understanding of baseline studies for new equipment Experienced in coverage testing and clean-into-service. 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. Education and Experience: 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.
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