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Senior Quality Control Specialist

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 health and well-being through innovative healthcare solutions. Our commitment to quality and excellence drives us to develop and manufacture a diverse range of pharmaceutical products that meet the highest standards of safety and efficacy.

Job Purpose

The primary role of the Senior Analyst, Quality Control is to oversee the implementation and maintenance of a comprehensive quality program that aligns with Sun Pharma's standards, as well as Canadian and FDA cGMP regulations. This position plays a crucial role in enhancing quality practices and ensuring compliance for all products manufactured, packaged, or tested at our facilities.

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 to the team.
  • Address and resolve test method and equipment challenges.
  • Manage the complete cycle of internal laboratory investigations, including trend analysis and preventive measures.
  • Deliver technical training to analysts on analytical methods and onboard new team members.
  • Conduct testing for in-process, bulk, finished goods, stability, validation, and investigation samples.
  • Lead method transfer initiatives.
  • Collaborate with the Quality Control Supervisor to prioritize tasks, coordinate workloads, and communicate team objectives.
  • Support internal and regulatory inspections.
  • Design and implement training programs to enhance team capabilities and ensure compliance with SOPs and regulatory requirements.
  • Identify and execute key process improvements to enhance operational efficiency and elevate GMP standards.
  • Perform other assigned duties as necessary.

Development Focus:

  • Oversee the development and validation of analytical methods within the QC laboratory, focusing on HPLC and other instrumental techniques.
  • Develop and validate cleaning validation methods as needed.
  • Conduct IV drug release testing for product comparison.
  • Manage process validation and cleaning validation testing.
  • Lead method transfer activities.
  • Facilitate new product introductions.
  • Troubleshoot product, method, and raw material issues.
  • Direct projects aimed at process improvement.
  • Work with the Quality Control Supervisor to prioritize tasks and coordinate team efforts.
  • Act as a Subject Matter Expert, providing technical assistance and guidance to the team.
  • Create 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 necessary.
  • Support internal and regulatory inspections.
  • Design and deliver training to ensure team technical capability and compliance with regulatory standards.
  • Identify and implement process improvements to enhance systems and elevate GMP standards.
  • Collect 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 non-conformance investigations.
  • Complete corrective and preventive actions (CAPAs).
  • Initiate and manage 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 in using analytical instruments (e.g., pH meter, viscometer, Karl Fischer apparatus, UV, IR, HPLC, GC, UPLC).
  • Familiarity with relevant software, including LIMS, Empower, and MS Office.
  • Strong understanding of Health Canada and FDA regulations.
  • Ability to influence and motivate others while maintaining integrity and trust through effective communication.