Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.
What You Will Achieve
In this role (Quality Assurance Coordinator - Contractor) , you will:
Batch Records Review and Release Activities:
Follow up and review of batch documentation and assure strict adherence to written procedures.Follow up applying of GMP rules during review of batch documentation.Batch Record Review and Archiving.Products finished goods approval on Pfizer ERP (Enterprise Resource Planning) system.Review and approval of Master Batch Records.Release of finished goods on RSD SFDA DTTS (Drug Track & Trace System).Execution and reporting of validation / qualification activities:
Process ValidationCleaning ValidationPackaging ValidationComputerized System ValidationEquipment QualificationUtilities Qualification (HVAC, purified water system, compressed air)Development of relevant Validation Master Plans and SOPs.Development of Validation Protocols and Reports.Process verification.Packaging verification.Cleaning verification.Equipment/systems Validation periodic review.Support in Quality Assurance department daily activities and tasks
Here Is What You Need (Minimum Requirements)
Bachelor’s degree of Pharmacy or related field.Ability to work effectively in a team environment, both within one's own team and interdepartmental teamsEffective written and oral communication skillsBonus Points If You Have (Preferred Requirements)
Experience at a manufacturing site.Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control managementStrong problem-solving skillsAbility to work independently and as part of a teamExcellent time management and multitasking abilities
Work Location Assignment: On Premise
#LI-PFE
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