Maintenance à United States

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.

In this role (Quality Assurance Coordinator - Contractor), you will:

• 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).

• Process Validation
• Cleaning Validation
• Packaging Validation
• Computerized System Validation
• Equipment Qualification
• Utilities Qualification (HVAC, purified water system, compressed air)
• Development of relevant Validation Master Plans and SOPs.
• Development of Validation Protocols and Reports.
• Process verification.
• Equipment/systems Validation periodic review.

• Bachelor's degree in Pharmacy or related field.
• Ability to work effectively in a team environment, both within one's own team and interdepartmental teams
• Effective written and oral communication skills

• 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 management
• Strong problem-solving skills
• Ability to work independently and as part of a team
• Excellent time management and multitasking abilities

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