Computer System Validation Lead

iTvorks,Inc; Princeton (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

iTvorks, Inc in Princeton, NJ is seeking a candidate with substantial experience in testing and validation to work from their client site in Foster City, CA. A strong background in managing large implementations and an understanding of change management procedures are essential.

The ideal candidate must have formal training or certification in Testing & Validation and excellent technical writing skills. Familiarity with applications such as SAP, Oracle EBS, LIMS, and VEEVA or Salesforce is required.

Qualifications

• Experience managing large implementations and upgrade projects.
• Formal training or certification on Testing & Validation is required.

Responsibilities

• Lead and manage testing and validation activities according to project scope.
• Handle change requests efficiently and independently.

Skills

Change management procedure

Testing & Validation certification

Technical writing

Cross-functional collaboration

Tools

SAP

Oracle EBS

LIMS

VEEVA

Salesforce

Job description

iTvorks provides answers to enterprises in a wide range of business sectors such as medical, real estate, and finance among others. We have reliably helped many organizations see their visions come to life by entirely managing the lifecycles of their products, infrastructure and applications.

Job Description

Candidate needs to work from our Client site Based in Foster City CA.

• 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 projects
• Strong knowledge on change management procedure & process; Should have handled more than 20+ change requests
• Hands-on knowledge of 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 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

Qualifications

Below applications Experience Must.

• SAP
• Oracle EBS
• LIMS
• VEEVA or Salesforce

Additional Information

All your information will be kept confidential according to EEO guidelines.

Job Location