Quality Assurance - Enteral Nutrition

Role & responsibilities

• To develop and implement comprehensive quality assurance procedures specific to enteral nutrition products.
• To ensure compliance with relevant regulations and industry standards in all aspects of enteral nutrition.
• To monitor and ensure compliance at Contract Manufacturing Operations through continuous document verification and periodic audits.
• To oversee the evaluation and testing of enteral nutrition products for safety, efficacy, and quality.
• To monitor product performance through data analysis, quality metrics, and prepare reports for management.
• To evaluate and manage change control processes to ensure that all modifications in products or processes are assessed for quality impact.
• To review, approve, and update Standard Operating Procedures (SOPs) related to enteral nutrition and CMO to ensure compliance and operational efficiency.
• To provide technical responses to queries raised by the Ministry of Health, ensuring accurate and timely information is communicated.
• To facilitate and participate in meetings with stakeholders to discuss quality assurance matters, product updates, and compliance issues.
• To conduct internal audits and ensure compliance with quality standards, regulatory requirements, and industry best practices.
• To manage all product CMO activities and release the batches manufactured at CMO sites.
• To manage all products derived by Otsuka as per business requirements.
• To undertake any additional responsibilities assigned by senior management that support quality assurance objectives.