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3+ 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. specializes in hiring entry-level candidates for positions in contract research for clinical trials involving drugs, biologics, and medical devices. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners to offer opportunities in Drug Safety, Pharmacovigilance, and Clinical Research.


Position Overview

Role: Computer System Validation (CSV) Specialist
Job Type: Contract


Key Responsibilities

  • Apply FDA, MHRA, and global regulatory standards to computer systems supporting regulated business processes.
  • Follow SOPs and industry best practices for documentation and testing.
  • Conduct training sessions on good documentation and testing practices.
  • Facilitate CSV Risk Assessments to identify regulations and validation deliverables.
  • Review validation deliverables for third-party supplier projects.
  • Collaborate with stakeholders to track computerized system needs and project validation statuses.
  • Assist in planning and documenting User Acceptance Testing (UAT).
  • Review key validation documents, including:
    • Design Specifications
    • CSV Risk Assessments
    • Test Plans and Scripts (Pre/Post Execution)
    • Traceability Matrix
    • Data Migration Plans
    • Release to Production Statements
  • Direct and oversee testing activities and provide guidance on quality issues affecting data/system integrity.
  • Prepare validation and test summary reports and ensure QA review.
  • Monitor regulatory trends and recommend appropriate actions to ensure compliance.

Qualifications

  • Proficient in MS Office Suite, Visio, and familiar with technology platforms as required for the project.
  • Experience with Documentum and creating documents adhering to existing standards.
  • Strong oral and written communication skills in English.
  • Expertise in Software Development Life Cycle Management (SDLC) and compliance with CFR 21 Part 11.
  • Ability to develop documentation for validated projects, including Validation Plans and Summaries.
  • Minimum 3 years of experience in producing software and business requirement documentation.

Additional Information

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