PRESTIGE BIOPHARMA LIMITED

4 days ago


Singapore PRESTIGE BIOPHARMA LIMITED Full time

Roles & Responsibilities Job Summary : The senior product quality executive position requires an individual with strong technical expertise in Biologics manufacturing to provide quality oversight of upstream and downstream operations conducted at Contract Manufacturing Organizations (CMOs). This role is critical in ensuring that manufacturing activities are conducted in compliance with GMP, internal quality standards, and regulatory requirements while maintaining a strong focus on product quality throughout the production lifecycle. Responsibilities: Manufacturing Oversight Provide quality oversight for Drug Substance and Drug Product (DP) manufacturing activities at CMOs. Ensure manufacturing operations adhere to approved Master Batch Records, Standard Operating Procedures, and regulatory requirements. Review and assess critical in-process parameters, deviations, and any potential impact on product quality. Support timely resolution of quality-related issues and ensure decisions prioritize product quality and compliance. Quality Review & Documentation Ensure that manufacturing deviations, OOS/OOT results, and non-conformances are properly documented, investigated, and closed in a timely manner. Participate in root cause analysis (and ensure corrective and preventive actions are effectively implemented. Review and approve batch-related documentation and quality records as required. Process & Product Knowledge Maintain a strong understanding of process development and scale-up. Support technology


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    Singapore PRESTIGE BIOPHARMA LIMITED Full time

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    Singapore PRESTIGE BIOPHARMA LIMITED Full time

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    Singapore PRESTIGE BIOPHARMA LIMITED Full time

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