Customer Market Quality Officer

3 days ago


مصر, Egypt Pfizer Full time

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



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