About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, 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 PropositionEmployees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in-house 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.RequirementsRole 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 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.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 equipmentExperienced 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.