Gurpreet Khalsa

Experience

1. Sr Qa Technical Manager

   Exelixis

   Apr 2023 — Present

   Perform review of manufacturing, testing, labeling/packaging batch records and batch dispositionCoordinate investigations with vendors and interdepartmental teams to resolve potential product quality issuesOversee the generation, review and/or disposition of internal and external documents used in GMP activities, including authoring work instructions and SOPsSupport implementation of quality systems, including departmental and corporate procedures, to ensure compliance with GMPsInterpret regulatory agency policies and guidanceReview documents submitted to regulatory agencies & recommend revision of proceduresSupport Quality Risk Management Process and the implementation of process and system continuous improvement initiativesReview and approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, sampling plans, test methods, specifications and protocols and reports for method validations and stability studiesResponsible for ensuring product complaint investigations meet regulatory and internal requirements.

Education

• Guru Nanak Dev University

  Bachelor