Senior Expert Science

2 weeks ago

Hyderabad, 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.

  • 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 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.
  • WHAT YOULL BRING TO THE ROLE:
  • 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.

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