Transport Validation and Compliance Lead

3 days ago


Bengaluru, Karnataka, India Biocon Biologics Full time

Biocon Biologics Limited is a fully integrated global biosimilars organization with a strong research pipeline of biosimilar molecules across various diseases.

We are seeking a Transport Validation and Compliance Lead to govern start-to-end activities related to shipping validations for our product portfolio across the globe.

Key Responsibilities:

  • To manage shipping-related notifications for temperature excursions, investigations, and other non-compliances
  • To liaise with QA and other teams to timely closure of SRNs/Deviations and facilitate immediate disposition of batches
  • To understand validation deliverables with regulatory and quality teams and ensure timely completion
  • To enable cost-effective improvement projects through risk assessment and QMS documents
  • To host and lead regulatory/customer audits to achieve zero critical observations

Secondary Responsibilities:

  • To ensure all QMS, SOPs, and qualifications are delivered on time without extensions
  • To initiate, plan, review, track progress, and measure QMS performance in line with approved SOPs and regulations
  • To coordinate and manage relationships with internal and external stakeholders for flawless execution of QMS activities
  • To identify potential risks and develop strategies to mitigate them
  • To present logistics compliance functions to senior leadership monthly
  • To ensure digital projects are effectively implemented with CFT collaboration
  • To handle regulatory, customer, consultant, internal, statutory, and safety audits and ensure compliance

This role offers a competitive salary range of $120,000 - $180,000 per annum, depending on experience and location. Biocon Biologics is an equal opportunities employer and offers a dynamic work environment with opportunities for growth and development.



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