Senior Quality Assurance Specialist

6 days ago


Bengaluru, Karnataka, India Apotex Full time

About Apotex Inc.

Apotex Inc. is a global health company that produces high-quality medicines for patients worldwide. With a presence in over 75 countries, Apotex employs almost 7,200 people in manufacturing, R&D, and commercial operations.

Job Summary

As a Senior Quality Assurance Specialist, you will be responsible for reviewing analytical data and documents, monitoring laboratory activities, and ensuring quality oversight on drug product analytical method development, validation, and verification. This role requires management of team members and establishing operational procedures for smooth product development.

Key Responsibilities

  • Review analytical documents and data generated by the ARD laboratory.
  • Review calibration and qualification reports for laboratory instruments.
  • Perform periodic electronic data reviews for laboratory analytical instruments.
  • Review and approve analytical method validation, method verification, and development protocols and reports.
  • Support the Development Quality Assurance team for analytical method development and validation activities.
  • Review and approve laboratory change controls, deviations, corrective/preventive actions, and laboratory investigation reports.
  • Review laboratory notebooks, stability protocols, and stability summary reports.
  • Review and approve raw material, in-process, and finished products analytical data.

Requirements

  • Education: M. Pharm/B. Pharm with 10-12 years of experience in Pharmaceutical Quality Assurance.
  • Knowledge, Skills, and Abilities:
    • Extensive knowledge of GMP and GLP requirements, specifically 21 CFR 210 and 21 CFR 211.
    • Experience with oral dosage formulations.
    • Previous exposure to R&D quality systems and documentation procedures.
    • Well-versed knowledge of regulatory guidelines (US, Canada, EU, TGA).
    • Team management and prioritization skills.
    • Effective communication and interpersonal skills.

At Apotex

We are committed to fostering an inclusive and accessible work environment where all employees feel valued, respected, and supported. We offer accommodation for applicants with disabilities as part of our recruitment process.



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