Senior Scientific Expert

2 days ago

Hyderabad, Telangana, India beBeeScientific Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Expert in Scientific Leadership

The successful candidate will lead and support the establishment and maintenance of a robust GxP management system for assigned ARD Line Units at site level. As a contact point between local QA and the ARD Line Units, they will facilitate general inquiries and provide guidance on GxP-related matters.

This role represents the ARD in various GxP-related committees and networks, fostering collaboration and knowledge-sharing opportunities.

Responsibilities:
  • Lead and manage all activities of assigned teams/projects to meet customer expectations.
  • Ensure compliance with quality standards, ethics, health, safety, environment, protection, and information security protocols.
  • Develop and maintain the GMP management system, monitoring adherence to internal and external regulations.
  • Oversee all GMP activities within the Unit, ensuring seamless execution.
  • Provide guidance and support to team heads and staff on GMP-related matters.
  • Monitor quality exception management, driving timely completion and resolution.
  • Support training programs and implementation of SOPs, GMP, GLP, QM, HSE, ISRM, and Novartis Guidelines.
  • Prepare, perform, and support GMP audits as required, including organizing and tracking follow-up action items.
  • Initiate continuous improvement initiatives.
  • Perform complex tasks without established procedures, leveraging expertise and judgment.
  • Oversee and author protocols, scientific reports, lab procedures, or process-related SOPs.
  • Develop scientific documents intended for external partners or registration documents.
  • Communicate, address, and resolve problems within their area of responsibility and beyond.

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