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.