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Quality Control Senior Analyst

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 people worldwide through innovative healthcare solutions. Our commitment to quality and excellence is reflected in our diverse portfolio of products and our state-of-the-art manufacturing facilities.

Job Purpose

The primary role of the Senior Analyst, Quality Control is to oversee the implementation and maintenance of a comprehensive quality management system that adheres to both Sun Pharma's standards and regulatory requirements. This position plays a crucial role in enhancing quality practices and ensuring compliance for all products manufactured, packaged, or tested within our facilities.

Duties and Responsibilities

Team Leadership Focus:

  • Supervise a team of analysts in conducting Good Manufacturing Practice (GMP) laboratory testing, providing guidance and technical expertise.
  • Facilitate the introduction of new laboratory protocols and technologies to the team.
  • Address and resolve issues related to testing methods and laboratory equipment.
  • Manage the complete cycle of internal laboratory investigations, including data analysis and preventive measures.
  • Conduct technical training for analysts on analytical methodologies and assist in onboarding new team members.
  • Oversee testing of in-process, bulk, finished goods, stability, and validation samples.
  • Coordinate method transfer initiatives.
  • Collaborate with the Quality Control Supervisor to prioritize tasks and manage team workload effectively.
  • Support internal and regulatory inspections.
  • Design and implement training programs to enhance team capabilities and ensure compliance with standard operating procedures and regulatory requirements.
  • Identify and execute process improvements to optimize systems and elevate GMP standards.
  • Perform additional duties as assigned.

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 IV drug release testing for product comparisons.
  • Manage process and cleaning validation testing.
  • Coordinate method transfer activities.
  • Facilitate the introduction of new products.
  • Address troubleshooting for products, methods, and raw materials.
  • Lead projects aimed at process enhancements.
  • Work with the Quality Control Supervisor to prioritize and coordinate team activities.
  • Act as a Subject Matter Expert, providing technical support and mentorship to team members.
  • Develop job rotation schedules and cross-training initiatives for Quality Control Analysts.
  • Collaborate with other departments to integrate quality into processes and systems.
  • Update and revise Quality Control procedures as required.
  • Assist in internal and regulatory audits.
  • Identify and implement key process improvements to enhance operational efficiency and compliance.
  • Gather and analyze data for reporting purposes.
  • Ensure timely completion of all GMP documentation and maintain training records.
  • Participate in and lead investigations into non-conformance issues.
  • Complete corrective and preventive actions (CAPAs).
  • Initiate and manage change control processes.
  • Engage in internal, customer, and regulatory audits.
  • Perform other duties as assigned.

Knowledge, Skills, and Abilities:

  • In-depth knowledge of analytical chemistry and instrumentation.
  • Proficient in the use of 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.
  • Comprehensive understanding of Health Canada and FDA regulations.
  • Ability to influence and motivate others while maintaining integrity and trust through effective communication.