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Validation Lead

Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
2+ years
Not Disclosed
10 Nov. 21, 2024
Job Description
Job Type: Full Time Remote 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

Job Title: Software Validation Specialist (GAMP 5)
Company: Katalyst Healthcares & Life Sciences
Location: Remote
Contract Type: Contract

Company Overview:

Katalyst Healthcares & Life Sciences is a leading provider of contract research services in clinical trials, working across a variety of therapeutic areas including drugs, biologics, and medical devices. We collaborate with top university hospitals, pharmaceutical companies, and recruiting partners to drive excellence in clinical research. We are currently hiring for multiple positions in Drug Safety, Pharmacovigilance, and Clinical Research.

Job Description:

We are seeking an experienced Software Validation Specialist with expertise in GAMP 5 to join our team. Ideal candidates will have experience validating software systems in the pharmaceutical or medical device industries, with knowledge of SAP validation preferred. The role requires proficiency in MS Project and Office 365.

Responsibilities:

  • Validate software systems in compliance with GAMP 5 guidelines.
  • Provide expertise in the validation of SAP systems (preferred) and other enterprise software applications.
  • Work closely with internal and external stakeholders to ensure systems are validated according to industry standards.
  • Document validation activities and ensure all required documentation is in place for audits and regulatory compliance.

Requirements:

  • Proven experience in Software Validation with a focus on GAMP 5 guidelines.
  • Experience validating SAP systems (preferred).
  • Strong proficiency in MS Project and Office 365.
  • Previous experience in pharma or medical device industries is highly preferred.

Additional Information:

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

Apply Now: Katalyst Healthcares Careers