Demo

IT Quality Lead (CSV)

Katalyst Healthcares & Life Sciences
Boston, MA Full Time
POSTED ON 1/27/2025
AVAILABLE BEFORE 4/24/2025

Qualifications :

  • Providing the validation strategy for different computer systems in life sciences industry
  • Possess expertise in managing acquisitions and divestitures from a Computer System Validation (CSV) perspective.
  • Comprehensive understanding of the Computer System Validation process, particularly in relation to GxP applications and systems.
  • Capability to remediate CSV Validation documentation.
  • Strong understanding of CFR 21 Part 11 and the SDLC lifecycle related to validation requirements.
  • Ability to work within a team and independently.
  • Strong English communication and written skills required.

Preferred Qualifications :

  • Previous experience working for an Innovative Medicine company is preferred.
  • Additional Experience Required :

  • Project Leader / Senior 3-7 years of relevant experience
  • Work independently and guide / mentor Junior resources
  • Experience in the Pharmaceutical, biotechnology, or medical device industry
  • 2 years' experience with System Development Lifecycle
  • 3 years' experience in Computer System Validation (Based on the role selected)
  • Experience in FDA and / or global regulated environment with good understanding of GxP standards and Risk based validation
  • Knowledge of FDA guidance and industry standards (i.e., GAMP)
  • Experience in writing and executing documentation for all aspects of the validation deliverables (requirements, compliance / validation plans, test protocols, test summary reports and compliance / validation reports)
  • Experience in reviewing system test and user acceptance test scripts, traceability matrix and design specs
  • Experience in QA Methodologies, designing, reviewing and approving test plans, systems and UAT test scripts and test procedures
  • Ability to work with remote teams and support several changes / projects simultaneously
  • Ability to provide validation guidance, timely reviews, and escalations to TQ management
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