Demo

Validation/Test Lead

SysMind Tech
Boston, MA Full Time
POSTED ON 1/22/2025
AVAILABLE BEFORE 4/22/2025

Relevant Experience

in Yrs)

10 years

Technical / Functional Skills

Validation / Test hands on in manufacturing / lab systems in pharma companies. Experience in Waters Empower system

Experience Required

Overall IT Experience : 10 years

Validation Lead / Test Experience : 5 years

Tools sets experience :

  • Micro Focus ALM (HP ALM)
  • MS Office tools set

Must have Experience :

  • Should have solid validation lead experience working for pharmaceutical companies as Val lead.
  • Should have great communication and coordination skills between internal team and customers across shores.
  • Should have good track record in managing teams to successful project delivery.
  • Should have solid experience in creating / executing best practices, guidelines, checklist GxP projects execution.
  • Worked in Life Sciences vertical both GxP and non GxP space.
  • Familiar with Life science business process flow.
  • Should have good understanding and experience on execution and managing GxP projects and deliverables.
  • Experience in systems like Waters Empower(Must) , LIMS, MES, etc will help.
  • Roles & Responsibilities

    As a hands on Val / Test lead is responsible for end to end validation and testing deliverables following Computer System Validation life cycle and also author, review, approve GxP / Risk Assessment, Val Plan, IQ, OQ, PQ, Val Summary, Traceability matrix, URS, FRS, Design documents

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