Training and Compliance Specialist Require at Novartis

 

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Training and Compliance Specialist

Job Description:
Job Purpose:
Assist in developing, coordinating and implementing training programs for new and experienced IIS personnel in support of the IIS training strategy and also ensuring regulatory compliance and inspection / audit readiness across all IIS functional groups.

Major Activities:
1.Develop methods to establish training plans for local IIS departments (including use of Training Needs Analysis) and ensure training (including materials, methods, availability and assessment) are aligned with IIS training globally.
2.Establish global induction plan for new hires and work with manager to establish approach to ensure training records are correctly logged, maintained and stored
3.Develop and maintain relationship with Pharma Development Training and other Novartis training colleagues
4.Assist in the revision of cross functional documentation and training materials when a process is updated or developed.
5.Work with partner functions to create cross functional training materials
6.Performs regular quality reviews of IIS documentation across IIS functional areas as scheduled.
7.Provides interpretation of GCP regulations, guidelines, policies and procedures, and provides sound guidance to Novartis personnel, both verbal and written.
8.Provides regulatory /compliance guidance and interpretation and represents IIS C & Q in internal and external meetings.

9.Participates in process improvement initiatives and collects appropriate metrics and provides periodic scheduled reports on progress against process improvement objectives.
10.Co-ordinates and takes part as necessary, in the preparation, timely issue, review, updating and archiving of Standard Operating Procedures (SOPs), Novartis Internal Procedures (NIPs), and Working Procedures.

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