Collins McNicholas

QA Engineer Responsibilities:

  • Develop Quality Management procedures and work instructions.
  • Proactively identify and resolve technical and compliance issues/gaps.
  • Review records and documents for completeness and compliance.
  • Lead and participate in interdepartmental initiatives for continuous improvement of procedures, processes, and systems and maintain a list of compliance initiatives.
  • Support quality management system validations as required.
  • Conduct and document training events particular relating to QA functional topics as required by internal training matrix.
  • Good understanding of risk management, and its application within the Quality Management System.
  • Plan and conduct scheduled audits to assess compliance with FDA, ISO, ICH, internal requirements (Internal and Supplier). 
  • Aid in the investigation and evaluation of audit findings. 
  • Support vendor qualification activities where appropriate.
  • Lead quality system corrective and preventive actions in the events of deviations or non-conformances.

QA Engineer Qualifications / Experience

  • Bachelor’s degree or higher, in any Life Science, Biomedical or related fields
  • Solid four years in a Pharmaceutical environment.
  • Good understanding of cGMP, 21 CFR Part 211, and related regulations associated with Pharmaceutical product manufacturing.

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