SME-Track and Trace

Job Description:

• Create detailed, comprehensive and well-structured test plans and test cases based on URS, FS, Technical specification.
• Review Functional specifications and technical Specification documents.
• Providing input & review the test deliverables like release notes, test summary reports, Impact analysis.
• Review all test data of manual and automation testing,
• Act as product expert assist Quality, Service , Development & customer when needed.
• Identify product and project risk and communicate to required stake holder.

Requirement:

• Must have strong understanding of GS1 Global and EPCIS
• Mandatory to have experience in track and trace regulations across the world:US DSCSA, EU FMD, Russia, UAE Tatmeen, Saudi FDA,DGFT, China Regulations etc.
• Understanding of Enterprise systems(L4) Like Tracelink, Rfxcel, SAP ATTP, SAP ICH.
• Exposure to pharmaceutical supply chain (CMO,MAH,3PLs, Wholesaler/Distributor)
• Working knowledge of Agile/Scrum methodologies and participiation in Agile ceremonies
• Good understanding of 21 CFR part 11, GAMP 5