- Bedford, New Hampshire, United States
- 2+ years
Ensure effective management and implementation of change controls, deviations, CAPA plans, and SOP updates within sterile fill finish operations.
Responsibilities
- Initiate, review, and manage change control documentation related to equipment, processes, and systems.
- Facilitate cross-functional communication to ensure alignment with stakeholders and timely resolution of change requests.
- Conduct impact assessments to evaluate the potential effects of proposed changes on product quality, safety, and efficacy.
- Lead investigations into deviations, identifying root causes and implementing corrective and preventive actions.
- Collaborate with Quality Assurance, Manufacturing, and other relevant departments to develop comprehensive deviation reports.
Requirements
- Bachelor’s Degree in a Science or Engineering related field