MES Consultant

Job Title: eBMR (MES) Consultant

About AmpleLogic: We're a trusted provider of GAMP solutions, specializing in empowering the life sciences industry through our advanced Application Platform as a Service (aPaaS) platform. Since 2010, AmpleLogic has been dedicated to developing industry-standard solutions that are effective, efficient, and competitive. With over 12 products deployed, including eQMS, LMS, DMS, and more, we have served 100+ life science companies worldwide. Our flagship product, eQMS, reflects our commitment to quality, compliance, and innovation.

For more information, please visit: https://amplelogic.com/

Location: HITEC City, Hyderabad (Onsite, 5 days)

Core Technical & Domain Expertise

- 5+ years of hands-on experience in eBMR / MES implementation within regulated pharmaceutical or life sciences environments - Proven expertise in end-to-end eBMR lifecycle including design, configuration, execution, review by exception (RBE), and batch release - Deep understanding of pharmaceutical manufacturing processes (Dispensing, Weighing, Granulation, Compression, Coating, Packing, Sterile / Non-sterile operations) - Strong experience working with MES/eBMR or equivalent enterprise MES platforms (We rum PAS-X, Siemens OpsCenter, Rockwell FactoryTalk, etc.)

Regulatory & Validation Expertise

- Expert-level knowledge of GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, WHO, MHRA, USFDA expectations - Extensive experience in Computer System Validation (CSV) for MES/e BMR systems - Ability to independently author, review, and approve URS, FS, DS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix - Experience handling data integrity requirements (ALCOA+) and audit trail reviews - Direct involvement in regulatory audits and inspections, responding to observations and CAPAs related to MES/eBMR systems

System Architecture & Integration Skills

- Strong knowledge of MES architecture, batch orchestration, master data management, and exception handling - Hands-on experience integrating MES/e BMR with: - ERP systems (SAP, Oracle) - LIMS, QMS, DMS - Automation systems (PLC, SCADA, DCS) - Working knowledge of REST APIs, web services, databases, and middleware - Ability to troubleshoot complex interface, performance, and data consistency issues

Interested candidates with relevant experience can share their resumes to sampurna.p@amplelogic.com