Lead 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 development and delivery of high-quality medicines. Our mission is to serve the healthcare needs of communities worldwide by providing innovative and effective healthcare solutions.

Job Overview

The primary role of this position is to execute method development, validation, and transfer tasks to support Quality Control and Operations.

Key Responsibilities

  • Develop and validate analytical methods within the Quality Control laboratory, focusing on HPLC and other instrumental techniques to enhance existing methodologies.
  • Establish and validate cleaning validation methods as necessary.
  • Conduct IV Drug release testing for comparative analysis of products.
  • Perform Process Validation and Cleaning Validation assessments.
  • Oversee Method Transfer activities.
  • Facilitate New Product introductions.
  • Troubleshoot issues related to products, methods, and raw materials.
  • Engage in projects aimed at process enhancement.
  • Collaborate with cross-functional teams to integrate quality into processes and systems proactively.
  • Create and update Quality Control procedures as needed.
  • Provide assistance during internal and regulatory inspections.
  • Identify and implement key process improvements to optimize systems, enhance site efficiencies, and elevate GMP standards.
  • Collect, analyze, and report data effectively.
  • Ensure all GMP documentation is completed accurately and promptly.
  • Complete all required training and maintain personal training records.
  • Participate in and/or lead investigations into non-conformance issues.
  • Execute Corrective and Preventive Actions (CAPAs).
  • Initiate and follow through on actions required to finalize Change Controls.
  • Participate in Internal, Customer, and Regulatory Audits.
  • Undertake additional responsibilities as assigned.

Required Knowledge, Skills, and Abilities:

  • In-depth knowledge of analytical chemistry and instrumentation.
  • Proficiency in using 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 objectives while maintaining integrity and trust.
  • Exceptional written communication and report writing capabilities.
  • Strong organizational skills with the ability to manage multiple tasks; detail-oriented.
  • Excellent problem-solving skills and sound judgment.
  • Advanced investigative techniques for troubleshooting analytical challenges.

Problem-Solving Skills:

  • Recommend changes and initiate investigations as necessary.
  • Report any deviations from procedures or systems to management with logical reasoning, data, and corrective actions.

Qualifications:

  • Bachelor's Degree in Chemistry or a related field.
  • 3-5 years of experience in the pharmaceutical sector within a Quality Control Laboratory.
  • Knowledge of Pharmaceutical Manufacturing and Packaging is advantageous.
  • Proven technical writing abilities.
  • Strong interpersonal and teamwork skills.
  • Demonstrated leadership capabilities, including coaching and training.

Working Conditions:

  • Ability to perform under pressure and adapt to changing priorities.
  • Willingness to support operations across different shifts.
  • Manage diverse responsibilities requiring attention to detail.
  • Work in both office and laboratory settings.

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