URGENT Req: Validation Lead - California

 

Hello,

 

Greetings from iTvorks. We have below requirements for our direct client and location is Forster City California.

Please reply back if you have relevant resumes.

 

 

Role	Experience	Mandatory domain	Mandatory validation skills	Application / Technology / Role specific skills
VL – Serialization   VE – 6 to 8 years	9 – 12 years	LS	21 CFR Part 210 / 211 GAMP 5 Risk Based validation / ICH Q9 hands on implementation knowledge Manufacturing, Distribution process and procedure 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 Leading and managing testing and validation activities in synchronization with project scope, schedule and objective Must possess formal training/certification on Testing & Validation Excellent communication skills Excellent technical writing skills Should be able to work independently with minimum supervision Should have worked in cross-functional environments and comfortable to liaison with business	Axway, MSCA, GEM, EBS
VL – EBS patching	9 – 12 years	LS	21 CFR Part 210 / 211 GAMP 5 Risk Based validation / ICH Q9 hands on implementation knowledge Manufacturing, Distribution process and procedure 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 Leading and managing testing and validation activities in synchronization with project scope, schedule and objective Must possess formal training/certification on Testing & Validation Excellent communication skills Excellent technical writing skills Should be able to work independently with minimum supervision Should have worked in cross-functional environments and comfortable to liaison with business	Minimum 3 items, mainly PTM and OTC - Hands on testing experience in Oracle EBS Plan to Make (PTM) 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 (OTC) 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
VE – Argus	6 – 8 years	LS	21 CFR Part 210 / 211 GAMP 5 Risk Based validation / ICH Q9 hands on implementation knowledge Manufacturing, Distribution process and procedure 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	Hands on experience of upgrade / implementation in Argus / ARISg Good to have – worked on Argus 7 to 8 upgrade

 

 

 

 

 

Best Regards,

Roopa Chougule || HR Manager (USA & CANADA) || ITvorks 

Desk (973)-795-8389 || Cell: (210)-923-9904 || Fax: (973)-756-4038

101 College Road E, 3^rd Floor -Suite 302, Princeton, New Jersey 08540.