Pharmaceutical Data Review Specialist

4 weeks ago


Fredericton, New Brunswick, Canada SUN PHARMA Full time

Job Summary

Sun Pharma is seeking a highly skilled Pharmaceutical Data Review Specialist to join our team. In this role, you will be responsible for performing critical in-depth reviews of scientific data for Quality Control laboratory documents under general supervision.

Key Responsibilities

  • Review and verify the accuracy and completeness of scientific data for Quality Control laboratory documents, including raw data from in-process, API/Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions.
  • Demonstrate a thorough knowledge of approved SOPs, 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 under the direction of QA management.
  • Support systems to ensure the successful completion of Departmental goals and objectives.
  • 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.
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).

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, 401(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.

Equal Employment Opportunity

Sun Pharma is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.



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