Quality Control Auditor

5 days ago

Thane, India IQVIA Full time

BASIC FUNCTION:
Serve as a Quality Control auditor to develop and maintain quality control validation programs to review all client deliverables produced by the Data Operations team (Data Management, Clinical Programming, SAS Programming, and Biostats).

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

- With guidance from Lead Quality Control Auditor(s) and Manager, responsible for quality control processes relating to customer deliverables for the Data Operations team.
- Electronic Database Capture (EDC) system validation (InForm, Rave, IBM CD, Viedocs) based on Data Management/Programming specifications. The EDC components typically include eCRF design, EDC Administration/Configuration settings, Edit Checks, Data Integrations.
- Understand and execute Quality Control validation template instructions / test plans to validate EDC system components against Data Management / Programming specifications, e.g. eCRFs, Edit Checks, Patient Profile reports, Ad Hoc reports, etc.
- Communicate validation findings / observations to Data Management and Programming following completion of the validation task and communicate potential improvements if needed.
- Work with team to revalidate the component(s) once Data Management and Programming update specifications (if needed) and make programming updates. The QCA will continue to work with Data Management and Programming to support the validation task through cycles of rework / revalidation until the component passes validation.
- Assure detailed and quality documentation practices adhered to for the Quality Control validation documentation to support customer and regulatory audits.
- Assure process compliance with all regulatory and IQVIA Biotech SOPs.
- May assist with QC validation and eTMF project audits.
- May assist with the evaluation of quality control processes and improvements.

KNOWLEDGE, SKILLS AND ABILITIES:

- Knowledge of clinical research process and methodology.
- Understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct of clinical research.
- Excellent organization, communication, documentation, and computer skills.
- Knowledge of quality control processes and procedures.
- Ability to act independently and with initiative required to resolving problems.
- Ability to pay careful attention to details and deliver quality work with a high degree of accuracy within expected timelines.

MINIMUM RECRUITMENT STANDARDS:

- Bachelor’s degree or equivalent and 6-12 months relevant experience
- Equivalent combination of education, training and experience

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