Work as Senior Expert Science & Technology at Novartis - M.Pharm, MSc Apply

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 : Senior Expert Science & Technology (GxP & Compliance)

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
• 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 transfer of know-how to other departments or external contractors, including troubleshooting and on-site training.
• Lead the optimization of project related scientific /technical activities or processes, co-ordinate local team(s) and guide development and implementation of new technologies.
• Provide scientific and technical guidance; actively foster knowledge exchange.
• Develop, mentor and coach other scientific associates, present scientific /technical results internally and contribute to publications, presentations and patents.
• Meet quality, cost and timelines in all assigned projects.

Candidate Profile
• M.Pharm / MSc with 10+ years of experience or PhD in Science (e.g. analytical/Pharmacy/Chemistry or equivalent) with 5+ years of experience.
• Recognized expertise in a GxP area with scientific as well as strategic background.
• Understanding of drug development processes and proficiency in quality principles driving drug development such as GMP and applicable regulations and policies.
• Clear understanding of current and anticipated regulatory and quality expectations.
• Broad scientific as well as strategic background Advanced coaching skills.
• Track record of innovation, creativity, problem solving and productivity.
• Successful work experience in inter-disciplinary and cross-cultural teams is preferred.
• Successful work experience in a matrix organization is preferred.
• Good oral, written (good experience in writing of scientific reports and filing documentation) and presentation skills are essential.

Additional Information
Experience : 10+ years
Qualification : M.Pharm / MSc
Location : Telangana
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : GxP & Compliance
End Date : 30th June 2025