Suresh Kumar Banothu Email and Phone Number

Having 15 plus years of experience in Pharmaceutical industry. LIMS Specialist with a broad range experience in IT Implementations, Architecture, Validation, Training and Support to GxP standards within the pharmaceutical industry. Special expertise in LIMS area, maintaining the Global LIMS applications in accordance to the GxP standards.Possesses good understanding of GXP (GLP, GMP and GCP) and regulatory requirements including familiarization of FDA ‘21 CFR Part 11’ guidelines, Computer System Validation, Testing (IQ/OQ/PQ), ITIL process, Change Management, Incident and Problem Management.Roll out / Implementation and Support, Requirement Gathering and Documentation (GxP), Upgrade Management, Validation Testing, Product Testing, Post Production Support & Maintenance, Interface Development projects (Template development) & End User Training.Conversant with quality procedures while executing projects. Specialties: - Waters SDMS- IDBS ELN- WatsonLIMS, Sample Manager- Pristima- LabVantage Samtrack,- PathData System Labware LIMSCrystal reportsOracle and SQL conceptsPharma Domain KnowledgeGXP (GLP, GMP and GCP) and regulatory requirements including familiarization of FDA ‘21 CFR Part 11’ guidelines.Computer System Validation, ITIL process, Change Management, Incident and Problem Management