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Quality Control Team Leader

2 months ago

Brampton, Ontario, Canada SUN PHARMA Full time

Company Overview

Sun Pharma is a global leader in the pharmaceutical industry, dedicated to improving the health and well-being of individuals worldwide. We specialize in the development, manufacturing, and marketing of high-quality healthcare products, with a strong emphasis on dermatological solutions.

Position Summary

The primary role of this position is to oversee the implementation and maintenance of a comprehensive quality management system that aligns with both corporate and regulatory standards. This role is pivotal in enhancing quality practices and ensuring compliance with industry regulations.

Key Responsibilities

Team Leadership Focus:

  • Guide a team of analysts in conducting Good Manufacturing Practice (GMP) laboratory evaluations, offering mentorship and expert guidance.
  • Facilitate the introduction of new laboratory protocols and technologies to enhance operational efficiency.
  • Address and resolve issues related to testing methodologies and laboratory equipment.
  • Manage the complete cycle of internal laboratory investigations, including data analysis and preventive measures.
  • Provide technical training to analysts on analytical techniques and assist in onboarding new team members.
  • Conduct testing for in-process, bulk, finished goods, stability, and validation samples.
  • Oversee method transfer initiatives.
  • Collaborate with the Quality Control Supervisor to prioritize tasks and communicate effectively with the team.
  • Support internal and external regulatory audits.
  • Design and implement training programs to ensure team compliance with standard operating procedures and regulatory requirements.
  • Identify opportunities for process enhancements to improve operational efficiency and compliance.
  • Perform additional responsibilities as required.

Development Focus:

  • Lead the development and validation of analytical methods within the Quality Control laboratory, focusing on HPLC and other instrumental techniques.
  • Establish and validate cleaning procedures as necessary.
  • Conduct intravenous drug release testing for comparative analysis.
  • Manage process and cleaning validation testing.
  • Facilitate method transfer activities.
  • Support the introduction of new products.
  • Troubleshoot issues related to products, methods, and raw materials.
  • Lead initiatives aimed at process improvement.
  • Coordinate with the Quality Control Supervisor to prioritize tasks and align team efforts.
  • Act as a Subject Matter Expert, providing technical support and mentorship to the team.
  • Develop a job rotation schedule and provide cross-training for Quality Control Analysts to ensure comprehensive proficiency across all programs.