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PCI
Bedford, NH, USA; USA_NH_Bedford_29Com
Source: PCI careers · View original posting
From PCI's posting. “We” and “our” refer to the employer.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
As the Engineering Compliance Specialist, you will play a pivotal role in ensuring the effective management and implementation of change controls, deviations, CAPA plans, and SOP updates within our sterile fill finish operations. You will collaborate with various departments to drive continuous improvement, maintain regulatory compliance, and enhance overall operational efficiency.
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.
Ensure timely closure of deviations while maintaining compliance with regulatory requirements.
Develop and execute robust CAPA plans in response to identified issues or areas for improvement.
Coordinate with cross-functional teams to implement corrective actions and preventive measures.
Monitor and track CAPA effectiveness, making adjustments as necessary to enhance long-term performance.
Act as a liaison between engineering, quality, manufacturing, and other relevant departments to ensure seamless communication and collaboration.
Provide regular updates on change control, deviations, and CAPA status to management and relevant stakeholders.
Foster a culture of proactive problem-solving and continuous improvement
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