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Serialization - Val lead with Oracle EBS + Fusion + Axway
Ref No.: 17-25758
Location: Foster City, California
Job Title: Serialization - Val lead with Oracle EBS + Fusion + Axway

Description/Comment: Must have strong knowledge on
- 21 CFR Part 210 / 211
- GAMP 5 Risk Based validation / ICH Q9 hands on implementation knowledge
- Manufacturing, Distribution process and procedure
- Hands on testing experience in Oracle EBS Plan to Make module

o Inventory Control, Inventory Tracking

o Production Control, Production Execution

o Quality Management

o Receiving
- Hands on testing experience in Oracle EBS Order To Cash module

o Pick and Pack Order

o Ship Order

o Managed Recall

o Return Goods Management
- Hands on testing experience in Oracle EBS to MES system, 3PL

o Purchasing

o Supplier Management
- Hands on testing experience in Oracle Fusion Middleware

o Requester, Provider and Median services for GxP interfaces

o Backup and Restore is plus

o Disaster Recovery is plus
- Hands on testing experience in Axway / Trace link

o Serial number generation and tracking

o Global Serialization requirements

o GS1 EPCglobal compliant, EPCIS
- Experience in managing large implementations / upgrade project
- Strong knowledge on change management procedure & process; Should have handled more than 20+ change requests
- Hands on knowledge on Deviation and CAPA Management