Quality Assurance Associate Iii
vor 7 Monaten
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
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. In this role, you will work with a team tasked to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture at the Pfizer Country Office (PCO). Your work will ensure that those systems are compliant with Pfizer and Regulatory authority expectations and will help to protect patients/customers from any product quality risk.
As part of the business support team, you are recognized as an advisor to other colleagues in your group due to your comprehensive knowledge and skills in your area and understanding of the larger organization. You are innovative in identifying solutions to problems by taking a broader perspective that benefits the organization. You encourage collaboration and communication within the team and across groups to influence desired outcomes. You train others and provide guidance to the team that helps us achieve our goal of providing the best healthcare to our patients.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- KPI program management for Global Quality Operations and reporting
- Responsible for Training coordination for Global External Quality teams
- Responsible for establishing and maintaining different IT tools for executing work to increase effectivity
- Responsible for establishing process for identifying and creating software solutions for data extraction from different IT systems
- Responsible for creating and maintaining the Power BI dashboard for External Quality KPIs
- Support new IT system implementation; may participate in testing functionality to support Quality operations processes
- Be a super user for some of the electronic systems e.g. Veeva, Oracle etc.
- Be ambassador of PGS Operational Excellence representing External Quality department
- Support regulatory inspections as process owner of Legacy Seagen CMO KPI process
- Write and review Standard Operating Procedures as needed
- Owner of the Process Improvements projects follow up process in External Quality
- Support Implementation of risk management in External Quality
- Responsible for maintaining the quarterly KPI and risk register of CMOs
- Responsible for providing External quality input to TO’s monthly score card
**Qualifications**:
Must-Have
- 3+ years’ experience in the regulated pharmaceutical industry,
- Experience in Project management and managing global action plans
- Good communication skills and proven ability to work well with senior internal and external stakeholders
- Experience with electronic documentation management systems preferred.
- Expert in working with Excel, power point and other office software’s
- Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality.
- Fluency in English speaking and writing is a must.
Work Location Assignment: Flexible
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