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Vendor Qa Analyst

1+ years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Audit Lifecycle Support - Quality Assurance (QA) - IQVIA

Job Overview
IQVIA is seeking a dedicated individual to support the data processing function for maintaining QA databases that support auditing system lifecycle programs across all Global QA business units. This role involves handling audit information through its full lifecycle, from audit identification to corrective and preventive action follow-ups.


Essential Functions

  • Database Maintenance: Ensure that audits are accurately entered into the QA system from audit plans and notifications. Keep the system updated as required.

  • Audit Follow-up: Follow up on audits through their full lifecycle, including:

    • Identifying and entering missing information related to planned audits.

    • Confirming audits performed and following up on report issuance.

    • Ensuring corrective and preventive actions are agreed upon.

    • Following up on overdue critical/major findings and entering audit findings into the system.

    • Ensuring the issuance and distribution of certificates as required.

  • Support Staff: Provide assistance by answering basic queries regarding the use of the Electronic Data Application (EDA).

  • Documentation Management:

    • Distribute contracted audit documentation as specified in the audit plan.

    • Track documentation for the entire audit lifecycle, including internal, external, contracted, customer audits, and regulatory inspections.

  • Reporting: Generate reports, tables, and graphs from the QA databases, including overdue information status reports.

  • Filing Systems: Maintain audit lifecycle tracking systems, including electronic filing of documentation and correspondence.

  • Feedback to Management: Provide regular feedback to management regarding the audit lifecycle system status.


Qualifications

  • Education: Associate’s Degree (preferred).

  • Experience:

    • 1 year of relevant experience in a quality/laboratory environment, including GXP and/or Quality Assurance experience.

    • Equivalent combination of education, training, and experience is also acceptable.

  • Skills:

    • Proficiency in word-processing, spreadsheet, and database applications.

    • Knowledge of GXP regulations and guidelines.

    • Strong organizational, communication, and team orientation skills.

    • Ability to initiate tasks and work independently.

    • Effective time management skills with the ability to manage multiple projects simultaneously.

    • Ability to establish and maintain effective relationships with coworkers, managers, and clients.


About IQVIA

IQVIA is a global leader in providing clinical research services, commercial insights, and healthcare intelligence to the life sciences industry. We are committed to accelerating the development and commercialization of innovative medical treatments to improve patient outcomes worldwide. To learn more, visit IQVIA Careers.


This position offers an opportunity to contribute to the efficient management of the auditing lifecycle within a global, dynamic company.