Laura Keating

Seven years experience in the pharmaceutical industry, as both a Quality Assurance Specialist and Technical Operations Specialist. Proven expertise in Good Manufacturing Practice (GMP) compliance, process improvement, root cause analysis, and cross-functional collaboration. Seeking a challenging Quality Assurance role to leverage my skills in ensuring operational excellence and regulatory compliance.

Professional Experience

Technical Operations Specialist
Pfizer - Grange Castle, Dublin, Ireland | Jan 2023 – May 2024

• Led manufacturing investigations in the Drug Substance Proteins production area.
  Utilized process monitoring software (PI Vision, Delta V Manufacturing Control System (MCS), Informa) for process deviation analysis.
• Applied problem-solving tools such as Method One to identify root causes.
• Developed and implemented Corrective and Preventive Actions (CAPAs) based on root cause analysis.
• Authored and managed manufacturing investigation reports within the Veeva Vault electronic Quality Management System (eQMS) to meet deadlines.
• Provided technical support and leadership in cross-functional teams for production issues.
  Facilitated interdepartmental Process Robustness meetings and drove process improvements.
• Presented change control proposals and managed records within the quality system.
• Delivered training and mentorship to colleagues in the Technical Operations role.

Quality Assurance Specialist

Pfizer – Grange Castle, Dublin, Ireland | Jan 2019 – Jan 2023 (Senior Specialist) | Sep 2016 – Sep 2017 (Graduate Program)

• Ensured compliance with cGMP, Pfizer Quality Systems, site policies, regulatory requirements, and industry standards.
• Provided quality oversight for manufacturing investigations, ensuring thorough root cause analysis, impact assessment, and CAPA implementation.
• Reviewed and approved production batch records and related documentation for Qualified Person (QP) disposition.
• Collaborated with QPs to ensure timely resolution of issues affecting batch disposition.
• Managed batch disposition schedules and reported disposition metrics.
• Attended the Change Review Panel as a QA representative, reviewing and approving change control records.
• Conducted cGMP compliance walkthroughs of production areas and provided backroom audit support as QA representative.
• Reviewed and approved updates to process-related documentation, including SOPs and batch records.
• Supported and led continuous improvement initiatives, and delivered training and mentorship within the QA function.
• Reviewed regulatory documentation prepared as part of filing activities for next generation products.

Operations Support Specialist

Pfizer – Grange Castle, Dublin, Ireland | Oct 2017 – Sep 2018 (Graduate Program)

• Managed the supplier complaints process, including communicating new defects to suppliers and raising supplier commitments within the quality system.
• Participated in weekly calls with suppliers to discuss open cases and monitor progress.
• Led key meetings, such as manufacturing investigations meetings and materials review board sessions.
• Updated process-related documentation, including SOPs and production batch records, to support process improvements, CAPAs, and new equipment introductions.
• Supported audit preparation by ensuring process and documentation readiness.

Master of Science - Clinical and Translational Research
University College Dublin, Ireland (2021 - 2023)

Bachelor of Science - Pharmacology
University College Dublin, Ireland (2012 - 2016)