- Participate in and lead investigation of deviations, risk assessments and changes, ensuring appropriate actions are implemented timely.
- Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
- Provide QA oversight to GMP readiness, technical transfers, regulatory approvals and clinical operations at the facility.
- Assist in the creation and maintenance of QA SOPs, metrics and reports in line with site requirements.
- Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
- Bachelor's degree, or higher (Science/Quality/Technical).
- 4-5 years' experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
- Previous experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
- Ability to think logically and be proactive under the variable schedules of a startup site.
- Previous experience in quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc.
- Knowledge of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
