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CQV Technical Lead

CQV Technical Lead

Katalyst HealthCares & Life SciencesIndianapolis, IN
22 days ago
Job type
  • Full-time
Job description

Responsibilities :

  • Coordination and maintenance of CQV.
  • Review of Protocols.
  • Execution of approved protocols including generating / closure of all protocol deficiencies (deviation).
  • Generation of maintenance plans within CMMS.
  • Generation of Qualification summary report Summary Report, Trace Matrix.
  • Generation of handover release form.

Requirements :

  • Document revision and Approval Follow-up for URS, TQPAS.
  • Require Onsite resource assigned at the site.
  • Trained on GMP curricula to support CQV activities.
  • Create New Documents and Support review and approval of the following documents.
  • Execution of approved protocols including generating / closure of all protocol deficiencies.
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