Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.
Ensure Quality Assurance Auditing policies and procedures are kept up to date and aligned with Pfizer Quality standards and Regulatory requirements.
Prepare and participate in Manufacturing and Supplier Quality Assessment Audits(MQSA) and Bohs Inspections of the site, ensuring successful results, and timely
implementation/closure of action plans, identifying and managing routine Customer Quality complaints for commercial Drug Products in the global complaints management system (PCOM), and interactions with the Contractor Quality organization if needed for ensuring that the investigation reports are appropriate and acceptable.
Assist Quality Control lab Supervisor with technical issues involving injector functionality, component testing, and protocol execution.
Contribute to quality assurance management team initiatives and objectives.
Assist in the process of gathering, interpreting, and applying statistical methods to various Production/Quality related processes and communicate those through reports, memos, files, and presentations.
Implement and adhere to {Current} Good Manufacturing Practices {part of GxP} regulations and company policies.
Conduct detailed audit testing in connection with the investigation of allegations of expense report fraud, conflicts of interest, and other violations of Pfizer policies and procedures or laws.
Assist in the review of area documentation and perform trend analysis on data, controls, and standards.
Qualifications
Must-Have
Bachelor’s Degree
3+ years experience
Demonstrated experience and skills in conducting and documentation quality investigations related to pharmaceutical / medical device manufacturing processes
Strong knowledge and understanding of Quality System functions, manufacturing/packaging processes, validations, engineering drawings, and basic statistical processes
Ability to understand and apply Quality Engineering tasks, and mathematical concepts especially as it relate to statistics and probability
Good technical writing skills, and communication as well as presentation skills
Working knowledge of Microsoft Office, Microsoft Projects, and Statistical Software.
