Quality Assurance

In-Process Quality Assurance Specialist (Sterile Products)

Responsibilities:

• Performed in-process quality assurance activities for sterile pharmaceutical manufacturing operations in accordance with cGMP guidelines and regulatory requirements from the U.S. Food and Drug Administration.
• Conducted line clearance before and after manufacturing operations to ensure proper equipment status, material segregation, and compliance with approved procedures.
• Performed in-process sampling of sterile products during manufacturing to verify product quality and compliance with approved specifications.
• Reviewed and prepared Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) to ensure completeness, accuracy, and adherence to standard operating procedures.
• Participated in batch record review and batch release activities, ensuring all manufacturing and quality documentation met regulatory and internal quality standards.
• Assisted in the review of Annual Product Quality Review (APQR) reports by compiling manufacturing data, deviations, and trend analysis.
• Verified adherence to Good Manufacturing Practices (GMP) and supported quality compliance during production operations.
• Investigated deviations, documented observations, and collaborated with production and quality teams to implement corrective actions.
• Ensured manufacturing and documentation activities complied with quality standards such as those from the International Organization for Standardization and pharmaceutical regulatory guidelines.
• Coordinated with Quality Control, Production, and Regulatory teams to maintain product quality and ensure successful batch release.

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