Manager - Transport Validation and Compliance

1 month ago

Bangalore, India Biocon Biologics Full time

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients worldwide.

Education : Bachelor's degree, master's degree

Experience : 15+Years

Role & responsibilities

Primary Responsibilities

  • To govern the start to end activities related to shipping validations for various product portfolio across the globe which triggers from regulatory, quality, partners/CMOs/improvement initiatives etc.,
  • To manage shipping related notifications for temperature excursions, investigation for shipments crossed the established TOR limit and other non-compliances. To liaise with QA and other CFTs to timely closure of SRNs/Deviations and facilitate timely immediate disposition of batches to ensure product availability in market & patients.
  • To understand the validation deliverables with regulatory and quality team and ensuring the same for timely completion to fulfil product filing.
  • To enable various cost effective and improvement projects through risk assessment and QMS documents.
  • To host and lead regulatory/customer audits to aim zero critical and major observations. To provide response to the audit observations and ensure it for timely closure.

Secondary Responsibilities

  • Ensure all QMS, SOPs and qualifications are delivered on time without any extensions.
  • Initiate, Plan, review, track progress & measure QMS performance in line with approved SOPs/regulations and appropriate quality tools.
  • Coordinate & Manage relationships with Internal & external stakeholders for flawless execution of QMS activities.
  • Identify potential risks and develop strategies to mitigate them.
  • To present FG -Logistics compliance functions to Senior leadership on monthly basis.
  • To ensure all digital projects are effectively implemented with CFT collaboration.
  • Handle regulatory, customer/consultants/Internal, statutory and safety audits and ensure compliance.
  • To review URS, Risk Assessment, Impact Assessment, Protocols, and Reports for the equipment and facility qualification.
  • Establishing and review of EHS objectives, targets and management programs in the department.
  • To support quality team regarding QMS review, PQRs, Trend report, facility review reports etc.
  • Timely escalation of the issues to senior management with respect to quality and safety.
  • To Adherence to CGMP and EHS norms as per the outlaid procedures and regulatory guidelines.
  • To ensure mandatory and periodic training are completed for self and team.
  • Adhere to the company's policies and ensure to align the warehouse activities to meet the company's business goals.
  • To provide timely response to all QA internal/external audit and implement CAPA holistically

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