Otsuka Pharmaceutical→

Quality Assurance - Enteral Nutrition at Otsuka… · Ahmedabad

Name: Tsenta
Availability: InStock

ExperiencedOn-siteAhmedabad

Skills

ComplianceQuality AssuranceNutraceuticalsQuality AuditCMONutritionContract ManufacturingThird Party Manufacturing

Job Description

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.