Primary Function/Primary Goals/Objectives:

The Quality Engineer is responsible for all validation and change control activities, document change control and management, management of exception reports, and quality related activities within the Asia Pilot Plant and Process Research Lab (PRL) to ensure consistency and compliance with Quality Systems.

Major Responsibilities:

  • Work closely with all functions to provide Quality Assurance design review support to Asia Pilot Plant projects.
  • Perform and assure that the Asia Pilot Plant validation program is executed consistently with Abbott Validation Policies.
  • Manage the change control process and system, as well as the validation system.
  • Responsible for the writing and review of plant procedures relating to areas of assignment and ensure that procedures meet Abbott’s policies and regulatory agencies.
  • Review and Maintain the Validation Master Plan and in development of project validation plans.
  • Provide a broad base of Quality Assurance support for validation, maintenance, and calibration functions.
  • Responsible for managing training systems and conducting related quality elements training.
  • Support and be part of core team for internal and external audits.
  • Conduct GMP audits of the Asia Pilot Plant and Process Research Lab as schedule.
  • Assure that all QA documents are current. Identifies gaps in plant documentation and systems and take necessary actions to correct.
  • Track and manage the records retention, destruction and archival management system
  • Lead and/or support investigations, Deviations and/or participate to resolve and troubleshoot Asia Pilot Plant and Process Research Lab exceptions and/or complaints.
  • Assist to ensure effective pest control management program is in place. Ensure any adverse pest trends are promptly investigated with actions taken to mitigate the event.
  • Support to ensure Environmental Monitoring program meet and comply to quality system requirement
  • Assist and coordinate ingredient readiness and finished product microbiological testing for finished product release.
  • Drive and implement continuous improvements to enhance operations and participate in related cross-functional projects.
  • Follow all GMP, Plant hygiene and Health and Safety Rules and Regulations in the plant.
  • Perform any other duties associated with the primary task and/or lead or participate in various continual improvement projects.


  • Degree in Science, Food Technology, Food/ Dairy Science or related Engineering discipline.
  • Possesses a thorough knowledge of Quality Assurance and Manufacturing processes (production, logistics, engineering and performance metrics).
  • Possesses technical understanding of different technologies, manufacturing quality systems and Clinical Operations and be able to provide consultation and recommendations to help improve compliance.
  • Has experience in working independently through troubleshooting issues. Experience in performing audits and Validation is preferred.
  • Has the ability to successfully interact and communicate with all organizational levels internally and externally.
  • Demonstrate the ability to manage several activities / projects at once, to organize/ prioritize work, to meet deadlines and to prepare plans and reports.
  • At least 3 - 5 years of relevant QA experience in pharmaceutical or food industry is preferred.

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Quality Engineer

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