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 provision of high-quality medications. Our mission is to innovate and deliver effective healthcare solutions that meet the diverse needs of our customers and communities.

Job Overview

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

Key Responsibilities

  • Design 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 protocols as necessary.
  • Conduct IV Drug release assessments for comparative analysis.
  • Perform Process Validation and Cleaning Validation testing.
  • 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 various departments to integrate quality into operational processes and systems.
  • Draft and update Quality Control procedures as needed.
  • Provide assistance during internal and regulatory inspections.
  • Identify and implement significant process improvements to enhance operational efficiency and compliance with GMP standards.
  • Collect, analyze, and report data for quality assessments.
  • Ensure all GMP documentation is completed accurately and promptly.
  • Fulfill all training requirements and maintain up-to-date training records.
  • Participate in and/or lead investigations into non-conformance issues.
  • Execute Corrective and Preventive Actions (CAPA).
  • Initiate and manage actions required to resolve 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.
  • Comprehensive understanding of Health Canada and FDA regulations.
  • Ability to effectively communicate and influence others while maintaining integrity and trust.
  • Strong written communication and report generation skills.
  • Excellent organizational abilities and capacity to manage multiple tasks with attention to detail.
  • Exceptional problem-solving skills and sound judgment.
  • Advanced investigative skills for troubleshooting analytical challenges.

Problem-Solving Capabilities:

  • Recommend modifications and initiate investigations as necessary.
  • Report any deviations from established procedures or systems to management, supported by data and corrective actions.

Qualifications:

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

Working Environment:

  • Ability to perform under pressure and adapt to changing priorities.
  • Flexibility to support work across different shifts.
  • Diverse responsibilities requiring meticulous attention to detail.
  • Work in both office and laboratory settings.


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