Job Overview:
Support the data processing function for the maintenance of the QA database(s) supporting the auditing system lifecycle programs and processes across all Global QA business units.
Essential Functions:
- Maintain the QA database(s) ensuring Audits when identified are entered onto the system from audit plans/notification documentation and The system is updated as required.
- Audit information is followed up as required, through the full audit life cycle including: Missing information relating to the planned audits is identified, obtained and entered into the system.
- Confirmation of audits performed.
- Follow-up of Report issuance.
- Follow-up until Corrective And Preventive Actions agreed.
- Follow-up of overdue Critical/Major findings. The full text of findings are entered onto the database from Sponsor/Regulatory audit reports.
- Ensure that certificates are issued and distributed as required.
- Provide support to staff by answering simple queries concerning the use of EDA.
- Ensure Contracted Audit Documentation is distributed as specified in the audit plan.
- Review and track documentation related to the Global QA auditing lifecycle (Internal, External, Contracted and Customer Audits, Regulatory Inspections Quality Issues, Corrective And Preventive Action and status of Critical / Major issues).
- Produce documentation from the QA databases, including status reports of overdue information, tables and graphs as required.
- Maintain the QA filing systems for audit lifecycle tracking, including electronic filing of documentation and correspondence.
- Provide timely feedback to line management on audit lifecycle system status as appropriate.
Maintain the QA database(s) ensuring Audits when identified are entered onto the system from audit plans/notification documentation and The system is updated as required.
Audit information is followed up as required, through the full audit life cycle including: Missing information relating to the planned audits is identified, obtained and entered into the system.
Confirmation of audits performed.
Follow-up of Report issuance.
Follow-up until Corrective And Preventive Actions agreed.
Follow-up of overdue Critical/Major findings. The full text of findings are entered onto the database from Sponsor/Regulatory audit reports.
Ensure that certificates are issued and distributed as required.
Provide support to staff by answering simple queries concerning the use of EDA.
Ensure Contracted Audit Documentation is distributed as specified in the audit plan.
Review and track documentation related to the Global QA auditing lifecycle (Internal, External, Contracted and Customer Audits, Regulatory Inspections Quality Issues, Corrective And Preventive Action and status of Critical / Major issues).
Produce documentation from the QA databases, including status reports of overdue information, tables and graphs as required.
Maintain the QA filing systems for audit lifecycle tracking, including electronic filing of documentation and correspondence.
Provide timely feedback to line management on audit lifecycle system status as appropriate.
Qualifications:
- Associate's Degree Pref
- 1 year of relevant experience in a quality / laboratory environment, including GXP and/or Quality Assurance experience. Equivalent combination of education, training and experience.
- Knowledge of word-processing, spreadsheet, and database applications.
- Knowledge of GXP regulations and guidelines.
- Effective organization, communication, and team orientation skills.
- Ability to initiate assigned tasks and to work independently.
- Ability to manage multiple projects.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Associate's Degree Pref
1 year of relevant experience in a quality / laboratory environment, including GXP and/or Quality Assurance experience. Equivalent combination of education, training and experience.
Knowledge of word-processing, spreadsheet, and database applications.
Knowledge of GXP regulations and guidelines.
Effective organization, communication, and team orientation skills.
Ability to initiate assigned tasks and to work independently.
Ability to manage multiple projects.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.