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Vendor Qa Analyst

2-3 years
Not Disclosed
10 Dec. 19, 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

Job Title: QA Audit Support Specialist
Location: [Insert Location]
Job Type: Full-Time

Job Overview:
Support the data processing function for maintaining QA databases that support the auditing system lifecycle programs across all Global QA business units.

Essential Functions:

  • Conduct quality assurance audits of vendors providing GXP services (GCP, GLP, GMP) within budget and timelines. This includes scheduling, conducting, reporting, and closing audits as directed by the lead auditor.
  • Enter and categorize audit/inspection findings into the eQMS.
  • Solicit follow-up information and close audit/inspection findings in the eQMS.
  • Review and approve Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans.
  • Review vendor documents, contacting vendor staff to resolve related questions.
  • Demonstrate a fundamental understanding of relevant GXP regulations, guidelines, and auditing techniques.
  • Distribute contracted audit documentation as per the audit plan.
  • Review and track documentation related to the Global QA auditing lifecycle, including audits, inspections, quality issues, CAPA, and status of critical/major issues.
  • Generate documentation from the QA databases, including overdue information reports, tables, and graphs.
  • Maintain QA filing systems for audit lifecycle tracking, ensuring proper electronic filing of documentation and correspondence.

Qualifications:

  • Associate’s Degree preferred.
  • 2-3 years of relevant experience in a quality/laboratory environment, including GXP and/or Quality Assurance. Equivalent combination of education, training, and experience is acceptable.
  • Proficient in word-processing, spreadsheet, and database applications.
  • Knowledge of GXP regulations and guidelines.
  • Strong organizational, communication, and teamwork skills.
  • Ability to work independently and manage multiple projects.
  • Ability to establish and maintain effective relationships with coworkers, managers, and clients.

Company Overview:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence, accelerating the development and commercialization of medical treatments to improve patient outcomes worldwide.

Job Function: Quality Assurance
Role: Full-Time