Suresh Kainth
Csv Manager @Convatec
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WORK HISTORY
Csv Manager @Convatec
EDUCATION
Challeny High School for Boys
GCSE, English, Mathematics and Science
Nottingham Trent University
2.2, Chemistry
Swansea University
Post Graduate Certificate in Applied LCMS, Mass Spectrometry
SKILLS
ABOUT SURESH KAINTH
Highly skilled analytical thinker with over 20 years’ experience in Pharmaceutical and Scientific sector with various roles within Quality, Technical Validation (Process, Utilities, Equipment and Computer Systems Validation), and Engineering. I have the ability and mindset to effectively identify and solve technical problems using established industry practices. KEY SKILLS & EXPERTISE Validation Skills: Validation on Equipment and Computer Systems Validation (CSV) to regulatory agencies e.g. FDA, MHRA and EU Directive EudraLex Vol 4 Annex 11 and 15. Industry Standards such as GMP, GLP, GCP, GDP, ISPE GAMP 5, 21 CFR Part 11, PIC/S, ICH Q9, ISO9001, ISO27001, ISO12207, ISO2859, ANSI/ASQ.Quality Management Systems: Skills and experience for Quality processes on GxP Equipment and Computerised Systems Validation (CSV). • Change Control, Deviations / CAPA process, Risk Management process. • Validation Lifecycle Processes entailing SDLC, Documentation Compliance, Strategy• Data Integrity compliance• Test Management Tool • Analysis tools.• Computerised Systems: Enterprise Resource Planning (ERP), laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), Quality Management System (QMS), Regulatory Information Management (RIM), Artwork – Packaging and Labelling, IT Infrastructure. Engineering Technical Skills: Based on Analytical instrumentation and GLP principals, highly knowledgeable with proven working experience in manufacturing and R&D sites to perform Installation, Preventative Maintenance (PM), Repairs, DQ, IQ, OQ and full validation consultation for customers on the following hardware and software: • Liquid Chromatography (LC)• Gas Chromatography (GC)• Mass Spectrometry (MS)• Balances (Bulk, Semi-Analytical, Analytical)• Spectroscopy - Infrared, UV-VIS • Analytical accessories – Heated Systems, Robotic Sampling Units, Cryogenic Cooling System.• Software (Cat 3, 4 and 5) DQ/IQ/OQ on full product range.
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