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Senior Quality Assurance Specialist

2 months ago

Brampton, Ontario, Canada SUN PHARMA Full time

Company Overview

Sun Pharma is a prominent global pharmaceutical organization dedicated to enhancing the quality of life through innovative healthcare solutions. Our commitment to excellence in the development, manufacturing, and marketing of high-quality medicinal products has positioned us as a leader in the industry.

Job Purpose

The primary objective of this role is to oversee the implementation and maintenance of a comprehensive quality program that aligns with both corporate and regulatory standards. This position serves as a pivotal force in advancing quality practices and protocols for products produced, packaged, or evaluated at our facilities.

Duties and Responsibilities

Team Leadership Focus:

  • Guide a team of analysts in conducting Good Manufacturing Practice (GMP) laboratory assessments, offering mentorship and expertise.
  • Facilitate the introduction of new laboratory protocols, operational processes, and technologies to the analyst team.
  • Address and resolve test method and equipment challenges.
  • Oversee 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.
  • Manage method transfer initiatives.
  • Collaborate with the Quality Control Supervisor to prioritize tasks, coordinate workloads, and ensure team alignment on objectives.
  • Support internal and regulatory inspections.
  • Design and deliver training programs to enhance team technical capabilities and ensure compliance with relevant regulations.
  • Identify and implement process improvements to optimize systems and elevate GMP standards.
  • Perform additional responsibilities 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 comparison.
  • Manage process and cleaning validation testing.
  • Oversee method transfer activities.
  • Facilitate the introduction of new products.
  • Troubleshoot issues related to products, methods, and raw materials.
  • Lead projects aimed at process enhancement.
  • Work with the Quality Control Supervisor to prioritize tasks and ensure team alignment.
  • Act as a Subject Matter Expert, providing technical guidance and support to the team.
  • Create job rotation schedules and implement 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 needed.
  • Assist in internal and regulatory inspections.
  • Design and deliver training to ensure team compliance with relevant regulations.
  • Identify and implement key process improvements to enhance systems and elevate GMP standards.
  • Gather and analyze data for reporting purposes.
  • Ensure timely and accurate completion of all GMP documentation.
  • Complete all training assignments and maintain personal training records.
  • Participate in and/or lead investigations into non-conformance issues.
  • Complete corrective and preventive actions (CAPAs).
  • Initiate and manage actions required to close change controls.
  • Engage in internal, customer, and regulatory audits.
  • Perform additional duties as assigned.

Knowledge, Skills, and Abilities:

  • Extensive knowledge of analytical chemistry and instrumentation.
  • Proficient in the use of 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 communicate effectively to achieve shared goals while maintaining integrity and trust.