Principal Quality Control Analyst

3 weeks ago

Brampton, Ontario, Canada SUN PHARMA Full time

Sun Pharma is a global leader in the pharmaceutical industry, committed to enhancing health and well-being through the provision of high-quality medications. Our mission is to cater to the diverse needs of our customers and the community by innovating, developing, manufacturing, and marketing superior healthcare products.

With a robust production facility and a dedicated workforce, we focus on delivering specialized dermatological solutions, including a wide range of creams, ointments, liquids, and gels.

At Sun Pharma, we prioritize creating a healthy, safe, and rewarding work environment for our employees. Our comprehensive reward packages are tailored to meet the needs of our diverse workforce and their families.

Job Purpose

The primary responsibility of this role is to oversee the implementation of a comprehensive quality program that aligns with Sun Pharma, Canadian, and FDA cGMP standards. This position plays a crucial role in enhancing quality practices and guidelines for products manufactured, packaged, or tested at our facilities.

This role may concentrate on one of the following areas:

  • Coordinating activities for a designated team to ensure optimal quality of work and adherence to schedules (Team Leader)
  • Leading projects focused on method development, validation, and transfer activities to support Quality Control and Operations (Development)

Duties and Responsibilities

Team Leader Focus:

  • Guide a team of analysts in conducting GMP laboratory testing, providing mentorship and technical expertise
  • Facilitate the introduction of new laboratory requirements, business operations, and technologies to the analyst team
  • Address test method and equipment challenges
  • Oversee the complete cycle of internal lab investigations, including trend analysis and preventive actions
  • Provide technical training to analysts on analytical methods and assist in onboarding new team members
  • Conduct testing for in-process, bulk, finished goods, stability, validation/verification, and investigation samples
  • Manage method transfer activities
  • Collaborate with the Quality Control Supervisor to prioritize tasks, coordinate workloads, and communicate team priorities
  • Support internal and regulatory inspections
  • Design and deliver training aimed at enhancing team technical capabilities and ensuring compliance with SOPs and regulatory requirements
  • Identify and implement key process improvements to enhance systems and elevate GMP standards
  • Perform other assigned duties

Development Focus:

  • Lead the development and validation of methods within the QC lab for HPLC and other instrumental techniques to enhance existing methods
  • Develop and validate cleaning validation methods as necessary
  • Conduct IV drug release testing for product comparison
  • Oversee process validation and cleaning validation testing
  • Manage method transfer activities
  • Facilitate new product introductions
  • Troubleshoot product, method, and raw material issues
  • Lead projects aimed at process improvement
  • Collaborate with the Quality Control Supervisor to prioritize tasks and coordinate workloads
  • 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
  • Work with other departments to integrate quality into processes and systems
  • Revise QC procedures as required
  • Support internal and regulatory inspections
  • Design and deliver training to ensure team technical capability and compliance with SOPs and regulatory standards
  • Identify and implement process improvements to enhance systems and elevate GMP standards
  • Generate, collect, and analyze data for reporting purposes
  • Complete all GMP documentation accurately and promptly
  • Fulfill all training assignments and maintain personal training records
  • Participate in and/or lead Non-Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPAs)
  • Initiate and follow through with actions required to close Change Controls
  • Participate in internal, customer, and regulatory audits
  • Perform other assigned duties

Knowledge, Skills, and Abilities:

  • In-depth knowledge of analytical chemistry and instrumentation
  • Proficiency with analytical instruments (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 communicate effectively to achieve shared goals while maintaining integrity and trust

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