Quality Mgr II
Detalhes do emprego
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- The complaint handling system for both regulated and non-regulated products based on the global complaint handling process.
- Represent the QMS as the Quality Management Representative per ISO requirements
- Serves as the primary point of contact for Notified Body audits and regulatory agency inspections
- Maintains and improves the site document management control, CAPA, internal audit, and supplier audit processes
- Supports the Quality Notification, Global Field Safety Notification & Ship Hold processes
- Organizes and conducts quality-related training to internal employees and distributors
- Maintains the Singapore controlled drug and poison licenses for the import and release of controlled drug products in Singapore.
- Supports Veterinary certificates or other government agency licenses activities for the Asia Pacific distribution center operation
- Manages the secondary assembly program at the Singapore Distribution Center
- Ensures the QMS for Asia Pacific region is effective and aligned with the Complany Quality Policy and quality objectives, fulfills both regulatory and customer requirements
- Supports the commercial organization for the supplier audit program.
- Maintains controlled drug licenses and execute operation control on the release of controlled drug products.
- Support export documentation such as coordinating of the Veterinary certificate and poison licenses to support distribution center operation.
- Supports Australia, New Zealand and Korea import permit activities
- Assess and resolve gaps between regulations and the quality management system
- Maintains, optimizes, and improves current complaint handling system based on global complaint handling policy
- Responsible for post-market actions based on divisions’ CAPA plan and local regulation requirements. Support Quality Notification, Global Field Safety Notification & Ship Hold
- Be responsible for managing local SOPs according to Global SOPs. Maintain document control process
- Organize internal and external audits of the quality management system
- Bachelor degree in Pharmacy. Professional pharmacist or intermediate certificate of clinical examination is preferred. Pharmacist registered with the Singapore Pharmacy Council
- At least 7 years' work experience in QA with 3 years management experience.
- Good spoken and written English ability
- Strong ability to work effectively with diverse responsibilities
- Excellent interpersonal communication skills
- SAP ERP experience is a plus
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