Quality Assurance Specialist

2 weeks ago

Fredericton, New Brunswick, Canada SUN PHARMA Full time
Job Summary

Sun Pharma is seeking a highly skilled 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
  • Conduct thorough reviews of raw data, including in-process, API/Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions.
  • Demonstrate a deep understanding of approved SOP's, compendia (USP, BP, and EP), ICH, FDA, and other regulatory guidances.
  • Ensure that all documents are in compliance with cGMPs and the site operating procedures.
  • Support systems to ensure the successful completion of Departmental goals and objectives.
  • Perform other tasks as assigned by the Manager.
Work Environment

This role will be based in an office environment with occasional visits to the lab environment.

Requirements
  • Minimum of a Bachelor's degree in a relevant field.
  • Knowledge of pharmaceutical analysis.
  • 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

Sun Pharma offers a competitive compensation package, including medical, dental, and vision coverage, life insurance, disability insurance, (k) savings plan, flexible spending accounts, and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time.

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