Senior Quality Assurance Manager

5 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, the company employs almost 7,200 people in manufacturing, research, and commercial operations. Through vertical integration, Apotex focuses on developing and selling generic, biosimilar, and specialty products.

Job Summary

The Senior Quality Assurance Manager is responsible for reviewing analytical data, documents, and calibration/qualification reports. This role involves monitoring activities in the Analytical Research Development Laboratory, ensuring quality oversight on drug product analytical method development, validation, and verification. The successful candidate will also manage team members and establish day-to-day operational procedures for smooth product development.

Key Responsibilities

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


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