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2+ years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

Katalyst HealthCares & Life Sciences Inc. is hiring entry-level candidates for various positions in contract research involving clinical trials of drugs, biologics, and medical devices. We partner with university hospitals, pharmaceutical companies, and recruiting firms to offer career opportunities in Drug Safety, Pharmacovigilance, and Clinical Research.


Position Overview

Role: Computer System Validation (CSV) Specialist
Job Type: Full-Time/Contract


Responsibilities

  • Ensure compliance with FDA, MHRA, and other global regulations in developing computer systems supporting regulated business processes.
  • Adhere to SOPs and industry best practices.
  • Conduct training on documentation and testing practices.
  • Facilitate Computer System Validation Risk Assessments to determine governing regulations and deliverables.
  • Review validation deliverables for third-party projects.
  • Maintain close communication with stakeholders to ensure alignment with system needs and validation requirements.
  • Assist in planning, executing, and documenting User Acceptance Testing (UAT).
  • Review critical validation documents, including:
    • Design Specifications
    • CSV Risk Assessments
    • Test Plans and Summaries
    • Data Migration Plans
    • Executed Test Scripts
    • Traceability Matrices
    • Release to Production Statements
  • Oversee testing and provide guidance on data/system integrity issues.
  • Prepare validation and test summary reports.
  • Support quality assurance (QA) reviews and compliance audits.
  • Establish and promote standard quality and validation practices.
  • Assess compliance practices independently and recommend corrective actions.

Requirements

  • Approve validated computer system change requests.
  • Monitor regulatory trends and suggest actionable improvements.
  • Advanced proficiency in Microsoft Office Suite and Visio; experience with Documentum is preferred.
  • Strong oral and written communication skills in English.
  • Ability to create documents adhering to established standards.
  • Expertise in 21 CFR Part 11 compliance and Software Development Life Cycle Management.
  • Minimum of 3 years' experience in software and business requirement documentation.

Additional Information

All candidate information will remain confidential in accordance with EEO guidelines.