Supply Operations Quality Specialist

Start free →

Or apply yourself on the official page →

About the role

Supply Operations Quality Specialist 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 and innovative. What You Will Achieve You will be a member of Pfizer’s dedicated and highly effective quality operations team. You will evaluate and review Pfizer’s clinical and commercial batches of pharmaceuticals. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies. As a SOQ Specialist, 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 explaining difficult issues and establishing consensus between teams. How You Will Achieve It • The key role of the SOQ Specialist is to establish and maintain an appropriate and sustainable Quality Management System and Quality Culture within the Pfizer Country Office (PCO) to ensure compliance with Pfizer and Regulatory Authority expectations. • SOQ Specialist is the main point of contact for the investigation and resolution of all product quality issues detected or originating in the PCO and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, Commercial, etc.) and Pfizer Global Supply (PGS) on such issues. • SOQ Specialist monitors the product quality and compliance activities within the PCO, to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP/GDP inspections. Key Accountabilities Resolution of Product Quality and Compliance Issues Deviation Management Investigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of the PCO and agrees and tracks preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc. Customer Complaints Handling Ensures that relevant customer complaints are dealt with effectively as the main responsibility. Manages the intake of product quality complaints from the local market and forwards them to the appropriate global teams. Tracks responses to product quality complaints. Develops and issues responses to complainants in a timely manner, if requested. Provides input from quality perspective to Commercial Departments for the resolution of customer complaints related to distribution activities. Notification to Management Informs PGS Quality Operations Management of significant deviations and complaints. Quality Management System Ensures timely implementation of all applicable Product Quality SOPs (issued by SOQ) within the PCO. Ensures that initial and continuous training programs are implemented and maintained for all relevant PCO colleagues. Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions. Inspections and Internal Audits Supports the Responsible Person (RP) in the preparation and coordination of GMP/GDP Regulatory Agency inspections. Supports preparation and coordination of Regulatory Agency inspections internal Pfizer aud

View the official posting →