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Senior Quality Assurance Specialist

2 months ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time

Job Summary

Sun Pharma is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will be responsible for performing critical in-depth reviews of scientific data for Quality Control laboratory documents.

Key Responsibilities

  • Perform thorough reviews of scientific data for Quality Control laboratory documents, ensuring completeness, integrity, and accuracy.
  • Demonstrate a deep understanding of approved SOPs, compendia, ICH, FDA, and other regulatory guidelines.
  • Ensure that all documents are in compliance with cGMPs and site operating procedures.
  • Support the development and implementation of quality systems to ensure the successful completion of departmental goals and objectives.
  • Collaborate with cross-functional teams to identify and implement process improvements.

Requirements

  • Minimum of a Bachelor's degree in a relevant field.
  • Knowledge of pharmaceutical analysis and regulatory guidelines.
  • Ability to review laboratory records with minimal supervision within the framework of cGMP/GLP for analytical laboratories.
  • Good understanding of EHS and OSHA safety guidelines.
  • Knowledge of USP, ICH, FDA, and DEA regulations.
  • Knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
  • Demonstrated excellent communication, verbal, written, and presentation skills.
  • A self-starter with a hands-on approach and a can-do attitude.
  • Intermediate-B1+ level of English language proficiency.

Experience

  • Minimum of three years of experience in a pharmaceutical environment with a minimum two years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV, and wet chemistry).

What We Offer

  • Competitive compensation package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
  • Comprehensive benefits package, including medical, dental, and vision coverage.
  • 401(k) savings plan and flexible spending accounts.