(XLF821) J:819 Associate Manager:Quality Compliance: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 Pfizers dedicated and highly effective quality assurance and control team. You will serve as a primary contact for managing product defect complaints. You will address and expedite product complaints in accordance with the companys complaint policy while ensuring compliance with regulatory agencies. Based on the feedback received, you will be relied on to suggest modifications to the existing manufacturing and packaging processes. You will maintain unified product defect investigation operating procedures and provide technical expertise to optimize the complaint processing systems. Your proactive problem solving approach will ensure that all complaints investigated and handled as per company policy. 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 commitment 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 onown projects within a team. Manage communications with local and regional stakeholders related to product quality complaints. Support audits and inspections to ensure compliance with activities for GMP/GDP (Good Manufacturing Practices/Good Distribution Practices). Ensure that the performance of the complaint handling process occurs in accordance with plant and company policy/procedures and curreny Good Manufacturing Practices part of GxP regulations. Lead product quality investigations and support/ follow up on agreed Pfizer actions to address product quality/compliance issues identified when product is in the marketplace. Work as Subject Matter Expert and reviewer for assigned Standard Operating Procedures SOPs. Analyze inquiry data to identify trends and communicates relevant information to Region and Pfizer Consumer Healthcare. Assist with completion or follow:up of audit Corrective and Preventive Actions (CAPAs). Review documentation related to the repackaging/relabeling operation. Compile Key Performance Indicator figures for reporting purpose. Compile, organize, analyze and interpret complaint data on a periodic basis. Facilitate product focused trainings. Qualifications Must:Have Masters degree. 6 + years experience. Working experience in Manufacturing or Quality Assurance. Must have working experience in handling of Complaints, Returns/ Recalls and associated documentation. Appropriate technical experience to manage expectations. Knowledge of the regulatory GDP/GMP compliance issues relating to manufacturing and distribution of medicinal products Excellent organization skills and the ability to manage multiple priorities Good collaboration, communication and interpersonal skills with local, regional and global colleagues Proficiency in using System Application and Products, Microsoft Word, Excel, Power Point, Visio Nice:to:Have Relevant pharmaceutical experience Experience with Electronic Quality Management Systems in pharmaceutical industry Supervisory experience Work Location Assignment:On Premise Pfizer is an equal opportunity employer and complies with all applicable equal employment opp
