Senior Expert Science

4 weeks ago


Hyderabad, Telangana, India Novartis Full time

Job Description Summary

Leads and supports establishing and maintaining the GxP management system of the ARD Line Units at site level, serves as a contact point between local QA and the local ARD Line Units for general inquiries, represents the ARD in GxP-related committees and networks. Lead and manage all compliance/project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals.

Job Description

Responsibilities include, but are not limited to:

Oversee and lead all activities of assigned teams /projects to meet customer needs. Work according to appropriate standards for quality, ethics, health, safety, environment, protection and information security. Establishes and maintains GMP management system and monitors compliance with internal and external regulations. Ensures compliance to cGMP. Oversees all GMP activities within the Unit, Advises and supports the team heads and staff regarding GMP issues, Monitors quality exception management and drives timely completion, Supports training programs and implementation of SOPs, GMP, GLP, QM, HSE, ISRM and Novartis Guidelines. Prepares, performs, and supports GMP audits as appropriate, including organizing and tracking any follow-up action items. Lead initiatives to ensure continuous improvement Perform complex tasks without having established procedures. Oversee and write protocols, scientific reports, lab procedures or process related SOPs. Write scientific documents intended for external partners or for generation of registration documents. Communicate, address and solve problems within own and broader area of responsibility. Communicate effectively across organizational interfaces. Lead the
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