Validation Analyst Job at Katalyst Healthcares & Life Sciences, Tampa, FL

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  • Katalyst Healthcares & Life Sciences
  • Tampa, FL

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Responsibilities:

  • Lead and manage change control processes for S/4HANA implementation in alignment with GxP and related SOPs.
  • Review project timelines to ensure sufficient time is allocated for GxP validation activities and documentation deliverables.
  • Prepare and maintain validation documentation (URS, FRS, IQ/OQ/PQ, Traceability Matrix, etc.).
  • Coordinate and support E-CAB and Stage Gate meetings, including presentation preparation.
  • Facilitate review and approval cycles with QA and business stakeholders.
  • Ensure compliance with tools and systems such as ALM, ISM, Track Wise, and VEEVA CDOS.

Requirements:

  • 12+ years of experience in IT Change Management or Validation roles, preferably in life sciences or other regulated industries.
  • Strong understanding of GxP, CSV, and regulatory compliance frameworks.
  • Familiarity with validation tools and documentation standards.
  • Excellent communication and coordination skills.
  • Experience working with cross-functional teams including QA, PMO, and business stakeholders.
  • Experience with ERP implementations.
  • Experience supporting audit readiness and inspection processes.

Additional Information



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

Job Tags

Contract work, Immediate start,

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