Quality Assurance Specialist

19 hours ago


New Brunswick, New Jersey, United States 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
  • Perform thorough reviews of scientific data for Quality Control laboratory documents to ensure completeness, integrity, and accuracy.
  • Develop and maintain a thorough knowledge 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 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 laboratory.

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

This is a full-time position with a competitive salary and benefits package. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply.



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