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The Key role of Pfizer SOQ is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Pfizer 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. SOQ is the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the DC and for interacting with the relevant stakeholders and local regulatory authorities on such issues. Coordinates and monitors the product quality and compliance activities at the DC to ensure that current regulatory expectations are met and facilitates internal and regulatory GDP inspections.
Job Responsibility:
Maintenance of the compliance to the local BOH regulations
Governance and internal organization
Quality Metrics
Training
Commitment tracking
Change Controls
Inspection and internal audit
Quality risk management
Notification to management (NTM)
Deviation management
Local Repackaging/Relabeling operations
Local Product disposition
Returns
Quality alert notice
Market action (special situation)
DC external service providers management and oversight
Quality agreements
Post-release activities
Archival management
Backup
Requirements:
Master’s degree in Quality management
2-5 years in the pharmaceutical or related regulated industry
Fluent in Arabic, French and English
Computer skills: Excel, powerpoint, word
Good knowledge in quality principles, concepts and basic technical skills