[23508MSCRMCV] Test Analyst with manufacturing and medical device exp in Naples, Florida

NO OPT.....NO H1 transfer 

Test Analyst with manufacturing and medical device exp

Work Location: Naples, Florida, 34108,USA

Contract duration (in months: 6

Target Start Date: 21-Nov-2016

Job Details: Review the demos of existing systems, create requirement documents, estimate effort, review test design/plans and test cases, ensure optimum test environment is setup, coordinate with client and internal team on status updates WITH the objective of ensuring the highest levels of service offerings to clients in testing WITHIN the guidelines, policies and norms of Infosys. 

Must Have Skills (Top 2 technical skills only)

• Must have knowledge of and testing experience in Labeling operations within a manufacturing company, scanners/printers, and GDSN/GS1 standards and Experience with UDI (pharma/med device). Should have worked with a medical device company. Should have knowledge of any labeling software 
  
• Should be a validation Analyst. Should have thorough Knowledge of compliance: 21 CFR Part 11, 21 CFR Part 820, and GXP Guidelines.
  
• Nice to have skills (Top 2 only)
  
• Excellent communication and Inter-Personal skills
  
• Team and Stakeholder management 
  
• Desired years of experience : 6
  
• Education/ Certifications (Required) : Certification in Regulatory Compliance & Standards

Top 3 responsibilities you would expect the Subcon to shoulder and execute:

• Test Strategizing, Test planning and execution for IQ/ OQ /cycles for labeling systems; in short all aspects of computer system validation life cycle, in accordance with FDA. Documentation should as per GDP standards.
  
• Defect management as per set protocols; Generate and publish progress/defect reports
  
• Liaise with various stakeholders , business team, offshore teams , perform work allocation , tracking and monitoring 

Regards,

Jeni Tailor

Talent Acquisition Specialist

Gemini Consulting & Services 

Phone : 314-272-3141|Fax: 314-400-7696

jenitailor@gemini-us.com | www.gemini-us.com 

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