Job description
Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What You Will Achieve You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of the company's mission globally. As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It- 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 (MSQA) and BOHs Inspections to the site, ensuring successful results, and timely implementation/closure of action plans, identify and manage routine Customer Quality complaints for commercial Drug Products in 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.
- Bachelor's Degree
- 3+ years' experience
- Demonstrated experience and skills in conduct and documentation of 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 towards Quality Engineering tasks, mathematical concepts especially as it relates to statistics and probability
- Good technical writing skills, and communication as well as presentation skills
- Working knowledge of Microsoft Office, Microsoft Project, Statistical Software.
- Master's degree
- Complaint investigation experience
- Experience with electronic laboratory systems
