Principal Analyst, Quality Assurance

4 weeks ago

Brampton, Ontario, Canada SUN PHARMA Full time

Company Overview

Sun Pharma is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through the development and delivery of high-quality medicines. Our commitment to innovation and excellence drives us to provide a diverse range of healthcare products to meet the needs of patients worldwide.

Job Purpose

The primary role of this position is to oversee the implementation and maintenance of a comprehensive quality management system that adheres to Sun Pharma, Canadian, and FDA cGMP standards. This role is pivotal in enhancing quality practices and ensuring compliance for products manufactured, packaged, or tested at our facilities.

This position may focus on one of two key areas:

  • Team Leadership: Coordinating a designated team to ensure the highest quality of work and adherence to schedules.
  • Project Development: Leading initiatives related to method development, validation, and transfer to support Quality Control and Operations.

Duties and Responsibilities

Team Leadership Focus:

  • Guide a team of analysts in conducting GMP laboratory testing, providing mentorship and technical expertise.
  • Facilitate the introduction of new laboratory protocols, operational processes, and technologies.
  • Address and resolve issues related to test methods and equipment.
  • Manage the complete cycle of internal laboratory investigations, including trend analysis and preventive measures.
  • Deliver technical training to analysts in analytical methodologies and onboard new team members.
  • Conduct testing for in-process, bulk, finished goods, stability, and validation samples.
  • Oversee method transfer activities.
  • Collaborate with the Quality Control Supervisor to prioritize tasks and communicate workload effectively.
  • Support internal and regulatory inspections.
  • Design and implement training programs to enhance team technical capabilities and ensure compliance with SOPs and regulatory requirements.
  • Identify and execute process improvements to optimize systems and elevate GMP standards.
  • Perform additional duties as assigned.

Project Development Focus:

  • Lead the development and validation of analytical methods within the QC laboratory, focusing on HPLC and other instrumental techniques.
  • Establish and validate cleaning methods as necessary.
  • Conduct IV drug release testing for product comparisons.
  • Manage process and cleaning validation testing.
  • Facilitate method transfer activities.
  • Oversee new product introductions.
  • Troubleshoot issues related to products, methods, and raw materials.
  • Lead projects aimed at process enhancement.
  • Coordinate with the Quality Control Supervisor to prioritize tasks and communicate effectively with the team.
  • Act as a Subject Matter Expert, providing guidance and support to the team.
  • Develop job rotation schedules and provide cross-training for QC analysts to ensure proficiency across all QC programs.
  • Collaborate with other departments to integrate quality into processes and systems.
  • Revise and create QC procedures as required.
  • Assist with internal and regulatory inspections.
  • Design and deliver training to ensure team technical proficiency and compliance with health and safety regulations.
  • Identify and implement key process improvements to enhance operational efficiency and elevate GMP standards.
  • Gather and analyze data for reporting purposes.
  • Ensure timely and accurate completion of all GMP documentation.
  • Maintain personal training records and complete all training assignments.
  • Participate in and/or lead investigations into non-conformance.
  • Complete corrective and preventive actions (CAPAs).
  • Initiate and follow through on actions required to close change controls.
  • Engage in internal, customer, and regulatory audits.
  • Perform other duties as assigned.

Knowledge, Skills, and Abilities:

  • In-depth knowledge of analytical chemistry and instrumentation.
  • Proficiency with analytical instruments such as pH meters, viscometers, Karl Fischer apparatus, UV, IR, HPLC, GC, and UPLC.
  • Familiarity with software applications including LIMS, Empower, and MS Office.
  • Strong understanding of Health Canada and FDA regulations.
  • Ability to influence and communicate effectively to achieve shared goals while maintaining integrity and trust.

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