Research and Development Professional

5 days ago


Karachi, Sindh, Pakistan Esquare Services (Pvt) Ltd Full time
Job Description

This is a key role that requires strong analytical and problem-solving skills to improve product, process, and analytical methods robustness. The ideal candidate will have a deep understanding of global regulatory expectations, project management, and knowledge of stability programs and shelf life determination processes.

Key Responsibilities
  1. Support appropriate specifications setting.
  2. Improve product, process, and analytical methods robustness.
  3. Develop analytical methods for raw materials used in new/BVO products.
  4. Conduct validation of new developed analytical methods for raw materials.
  5. Conduct verification of available Compendia analytical methods for raw materials.
  6. Develop stability indicating analytical methods for new/BVO products.
  7. Conduct validation of newly developed analytical methods for new/BVO products.
  8. Conduct verification of available Compendia analytical methods for new/BVO products.
  9. Arrange reference standards and impurities for the development of new stability indicating analytical method.
  10. Support implementation of Process Analytical Technologies (PAT) to achieve real-time release.
  11. Conduct validation on first three commercial scale batches.
  12. Conduct real-time stability studies on first three commercial scale batches.
  13. Support in the development of artwork of packaging components.
  14. Lead/direct appropriate analytical method validations, transfers, and other supportive activities between development centers, sites, external suppliers, etc.
  15. Provide clear and timely analytical investigations of any product counterfeiting/customer complaint/contamination events supporting issue resolution with appropriate communication, escalation, and closure.
  16. Support in bio-equivalence/bio-availability studies of the new/BVO products.


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