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Pharmaceutical Team Leader
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DESCRIPTION
- Individuals in this role supervise and quality control the compilation, maintenanceand updating of Regulatory Documentation and associated data in the client
- Regulatory database system, documentation version control
- Optimizing utilization, and effective Resource Allocation planning for the team
- 100% compliance for work allocation
- Good Team Management (Indicated through good Skip level feedback and no major escalations)
- Ensure adherence to Cognizant and Client SOPs (Standard Operating Procedure)
- Responsible for regular FMEA update
- Complete all mandatory training courses as applicable
- Effective risk management and issue handling by conducting daily huddle and escalating them on time to time
- Provides support to the following processes:
- EVMPD
- Global Labeling
- Submission Management
- Compliance Data Management
- Develops and mentors the associate by providing expertise applicable to their region of responsibility
- Leads a delivery team, manages people.
- Coordinates and triages all work activity.
- Provides input into BI processes and software to Engagement Manager for communication back to BI.
- QCs work through spot checks on a regular basis.
- Understands Client expectations.
- Ensures training completion and compliance to applicable CTS and BI "Quality Management System"
- To ensure that the PGTP is compliant as per the Project requirements & SOP for Training at Cognizant Intuitive Operation & Automation (IOA)
- To ensure team is in compliance to applicable CTS and BI "Quality Management System"
REQUIREMENTS
- Bachelor degree in life sciences/pharmacy with 3-5 years of experience in Regulatory
- Affairs, PV Data handling
- Electronic Regulatory Database usage
- English (required actual work execution)
- Good verbal and written communication skills
- Knowledge of product life cycle management from regulatory perspective would be an added advantage
ARE YOU THE PERFECT CANDIDATE?
