Job Description

Job Summary

This role provides quality oversight of plant operation and laboratory processes to ensure adherence to cGMP requirements, regulatory requirements, corporate policies and established procedures. This position is responsible for promoting and maintaining regulatory standards compliance, supporting continuous improvement initiatives, and driving data integrity programs to strengthen quality systems and operational excellence.

Essential Duties and Responsibilities

  • Support in maintaining compliance with cGMP standards within the laboratories.

  • Provide GMP support for activities such as method validation, method transfer, instrument qualification, and verification of compendial test methods.

  • Provide technical guidance on calibration of analytical instruments, validation of Excel spreadsheets, and implementation of computerized systems.

  • Perform data audits and periodic reviews of laborato...

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