Experience with Pharma industry Global Track and Trace Serialization system realization and deployments, including hands-on experience implementing SAP ATTP.
Understanding of global serialization regulations and experience installing, configuring, deploying, documenting and testing system to meet specific business requirements.
Knowledge of global pharma industry standards/guidelines to enable serialization for manufacturing, logistics
ATTP Configuration like Rule, GCP, Serialization Profile, GTIN and its Range setup, etc., - Hands on configuration to realize business requirements.
Experience rolling out compliance modules in ATTP (EU-FMD, Bahrain, Brazil, USSC, etc.,)
Hands on experience in CMO onboarding.
Good understanding of SAP Track and Trace Solutions and GS1 standards e.g., GTIN, SGTIN, SSCC, GLN, SGLN, GCP
Should have strong understanding on XML file based data exchange and strong analyzing skill on XML
Should have strong knowledge of Serialization Master data setup.
Monitor every inbound and outbound data transmission in the ATTP system.
Trouble shoot any failed EPCIS events/messages and identify the root cause and work with Serialization team, IT team and Packaging to resolve the issue.
Experience working with change controls and GxP validation protocols
Hands on Configuration experience, identify gaps and design solutions to implement to fill those gaps, prepare functional specifications and elaborating requirements to technical counterpart and help them deliver technical solutions.
Testing the solution and supporting business during UAT
Work closely with other functional and technical team members.
Numbers & Facts
Location
CA
Skills
Acceptance Testingunmatched
Analysis Skillsunmatched
Biotech and Pharmaceuticalunmatched
Business Supportunmatched
Change Controlunmatched
Consultingunmatched
Documentationunmatched
GCP (Good Clinical Practices)unmatched
GxPunmatched
Identify Issuesunmatched
Industry Standardsunmatched
Logisticsunmatched
Manufacturingunmatched
Onboardingunmatched
Problem Solving Skillsunmatched
Regulationsunmatched
Root Cause Analysisunmatched
SAPunmatched
Team Playerunmatched
Technical Deliveryunmatched
Testingunmatched
Validation Planunmatched
XML (EXtensible Markup Language)unmatched
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