• Organization overview
  The key role of Pfizer SC&MOQ is to establish and maintain an appropriate and
  sustainable Product Quality System and Quality Culture within Pizer and any
  contractor related to GMP/GDP activities, so that compliance with Pfizer and
  Regulatory authority expectations and protection of Pfizer patients/customers
  from any product quality risk are ensured.
  Pfizer is committed to ensure equitable access to its brands in E2E supply
  chain cycle through the globe.
  Role description and Main responsibilities
  Support Go-To- Market capabilities for the AfME region:


• Provide technical quality input to Go-To- Market capabilities drive successfully working with local/ Regional teams, sales intermediary and third parties service providers in AfME region.


• Auditing


• Proactively assess business and quality risk through conducting initial risk assessment for sales intermediary and third parties service providers in AfME.


• Conduct Quality Due Diligence (QDD)assessment for sales intermediary and third parties service providers in AfME to ensure compliance to GDP requirements and Pfizer quality standards and Local Regulations.


• Review QDD results and identify the severity of audit findings or the risk associated with the findings to ensure the appropriate level of action is taken to eliminate non- conformance.


• Set up and approve corrective and preventive actions with sales intermediary and third parties service providers in AfME in order to achieve compliance.


• Participate in preparation and coordination of sales intermediary and third parties service providers inspections in AfME.


• Governance & internal Organizations :


• Responsible for the timely implementation of all applicable GSOPs .


• Assess new or proposed quality system/local regulatory requirements and adjust/enhance local systems and processes when required.


• Timely implementation of all applicable GSOPs.


• Ensure SCQs and all relevant PCO colleagues are appropriately trained in the Product Quality SOPs.


• Highlight any significant trends and identify actions.


• Ensure metrics are tracked in the global system.


• Commitment Tracking Managements.


• Change Controls managements.


• Product Quality assurance & Operations:
  Notification to Management


• Notifies SCQ cluster and Regional Lead of significant product quality and compliance issues.


• Attend AQRT meetings, as PCO representative, to provide the local perspective on the issue at hand.


• Provide AQRT Executive Summary including local investigation results and proposed CAPAs for issues originating under the responsibility of the PCO.


• Deviation and CAPA Management


• Review and approve investigation of product quality incidents that occur within the Span of responsibility in cooperation with the relevant internal/external functions.


• Set Up and approve CAPA to ensure compliance to Pfizer quality standards .


• Market Business & global Support


• Actively participate in market forum as spokesperson on quality topics.


• Foster and grow departmental communications and networking to assist with the quality reviews and crises management.


• Participates in business initiatives giving advice and assessing the impact to product quality and compliance.


• Ensure effective communication and collaboration with Pfizer (PCO/affiliate) internal stakeholders to ensure alignment and optimal support, launches and continuous availability of Quality compliant Pfizer product.


• Ensure effective communication to global/regional quality functions about local GMP and other regulatory requirements to ensure appropriate support and documentation for Pfizer products quality compliance release and maintenance in (PCO/affiliate)


• Work closely with other platform lines to achieve process development and improvements as ONE Pfizer.


• Actively promote the SCQ team


• Qualifications/Skills


• ‎5-‎7 years' experience in the Pharmaceutical or related regulated industry.


• Has an appropriate education in science or quality topics; Bachelor's degree, pharmacist, Engineer.


• Hascomprehensive knowledge of the quality principles, concepts of quality and comprehensive technical experience.


• Has strong technical experience with quality systems.


• Able to work and contribute effectively in cross-functional team, culture differences, diversity.


• English fluent Is must, French fluent Is advantage.


• Auditing certificate is advantage.

Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control

LI-PFE