Quality Assurance Specialist

1 day ago

Bandar Sunway, Malaysia Bright Prospect Full time

Bachelor's degree or equivalent in Science, Data Science, Pharmacy or related discipline
- At least 2-3 years experience in **Quality Assurance / QMS**:

- Applicant from **Medical Device or Pharmaceutical** Industry is added advantage
- Basic knowledge and understanding of Good Manufacturing Practice and Good Distribution Practice standards, as well as the key elements of a quality organization
- Excellent interpersonal and communication skills
- Able to develop and maintain strong collaborative relationships within the immediate team and other functional stakeholders
- Meticulous with strong analytical and critical-thinking skills
- **Immediate** vacant

**Responsibilities**:

- To execute of Quality activities related to the registration, import, supply, distribution and post-market surveillance of products in the South East Asia market.
- Support the product quality complaints and adverse event handling process for the site.
- Support the execution of activities related to Stop Shipment, Quality Holds, Field Notifications and Field Actions
- Support the creation and execution of CAPAs and Change Controls
- Monitor and report for timely completion of Quality records
- Support key quality metrics monitoring and reporting
- Provision of training to employees on quality related documents and policies.
- Support internal and external audit plan, conduct audit to distributors, co-packers, 3rd party service providers, materials and suppliers
- Product inspections and temperature data monitoring
- Provide support to ensure compliance and audit-readiness to company Quality Policy Standards and applicable procedures.
- To ensure regulatory compliance and business continuity.

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