IQVIA
Website:
iqvia.com
Job details:
Work Experience: 5-8 years
Work Location: Mumbai/Bangalore
Work Mode: Hybrid
Must Have Skills: Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPVP), Corrective and Preventive Actions (CAPA)
Job Profile Summary:
Provide Quality Assurance support in managing assigned Quality Events in accordance with the IQVIA Process/System requirement. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies, support in QA initiatives/projects for quality process improvements.
Responsibilities:
- Review, approve investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans and track till closure for Quality Issues and findings.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Manage/oversee quality events updates in electronic quality management system (eQMS) and/or maintain the eQMS and provide support related to the Quality Events lifecycle.
- Provide consultation to internal stakeholders on interpreting audit/inspection observations and formulating CAPA plans.
- Assist in training/Onboarding of new Quality Assurance staff.
- Accurate reporting and documentation of robust CAPAs in the electronic quality management system (eQMS) and adequate tracking of corrective and preventative actions and effectiveness checks for completion within the required timelines.
- Lead/collaborate/support QA initiatives/projects for quality, process/system improvements and departmental goals.
- Perform other work activities as assigned by the Line Manager. Participate in regular supervision. Attend all mandatory training. Participate annually identifying, developing and agreeing own development plan with Line Manager. Comply with all IQVIA policies, procedures and protocols. Seek advice and support from Line Manager whenever necessary. Maintain professional conduct at all times.
Educational Qualification: Bachelor’s or Master's Degree in Computer Science, Information Technology, Clinical Information Management or equivalent qualifications.
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