Durga Prasad Valavala

Only implementation and pre-sales consultant in a newly formed team. • Fraunhofer FFB, Münster (Dec 2025 – present, Go-Live planned Nov 2026): integrated LIMS/ELN/SDMS – requirements workshops, Qualis LIMS and Logilab ELN configuration, IQ of 6 applications across Test/Prod, 5-day onsite UAT. • Coordinated ADS integration; documented LIMS–MES API contracts with the vendor. • Pre-sales: EU public LIMS tenders (eVergabe, TED, TenderNed), LIMS/QMS demo for InfectoPharm, AR/VR GMP operator-training design.

• Configured L7|ESP LIMS workflows and schedulers for a CRDMO's QC biologics and microbiology labs (proof of concept); certified L7|ESP Super User. • Built test-execution workflows with barcode scanning, SOP-linked instructions and automated result charting. • Designed an ESP-based automation concept for preclinical GLP study lifecycle and archiving. • Delivered the first MES demo (eBR, review by exception) to a major Indian vaccine manufacturer; webinar "Paper to Pixels" for 200+ professionals.

• Managed LIMS master data and configuration for global pharma clients (Johnson & Johnson, Aspen Pharma) on LabVantage and LabWare. • Worked under regulated change control and data-integrity requirements (GxP). • Coordinated delivery between consultants, client IT and laboratory teams; gathered user requirements and supported end users.

• Analytical testing of oral solid dosage forms (dissolution, assay, related substances) for ICH stability, release and development batches in a cGMP QC lab. • Acquired, processed and second-person reviewed chromatographic data in Empower 3 and Chromeleon (Waters, Agilent, Shimadzu HPLC; Dionex IC) under ALCOA+ and 21 CFR Part 11. • Supported OOS/OOT investigations; worked with QA, R&D and vendors on instrument maintenance and qualification.