QA specialist, Baxter

QA specialist

Baxter

Location:

Hong Kong, Quarry Bay

Category:

Quality Control

Contract Type:

Employment contract

Salary:

Not provided

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Job Description:

As a QA specialist at Baxter, you will be responsible for ensuring product quality and compliance with regulatory standards in Hong Kong and Macau. This includes QA activities like product release, customer complaint handling, managing quality management systems, MDR compliance, and engaging in cross-functional audits. The role also involves collaboration with suppliers and distribution networks to maintain high-quality standards.

Job Responsibility:

Perform and handle QA activities in general office, including but not limited to: product release, product return and repackaging related activities to ensure the compliance of GMP, GDP, Baxter’s requirement, Hong Kong and Macau regulatory requirements
Handle customer complaints effectively (including but not limited to: complaint sample handling), ensure timely closure and escalation of quality incident and maintain customer satisfaction according to Baxter’s requirement
Prepare complaint investigation report
Monitor and review complaint metrics against targets to provide oversight for improvement
Coordinate cross-functional team and 3rd party’s warehouse to prepare internal audit and DH inspection
Manage supplier qualification process
Conduct audit to 3rd party warehouse as an audit team member
Coordinate with cross-functional team and regional Supplier Quality to ensure Baxter’s requirement is met
Support to manage 3rd party’s and distributor’s warehouse performance
Ensure implementation of Baxter Quality Management System at local level includes document control management
Support for NCR/ CAPA and change control
Handle ad hoc projects as assigned by QA Lead
Tracking regulation issue and update for medical device MDR
Maintain an efficient MDR system in compliance with the local authority’s regulation and Baxter Global Requirements
Provide MDR awareness training to all staff and vendor in Baxter Hong Kong office
Handling MDR reporting and submission according to Baxter and Hong Kong regulatory requirements
Track MDR cases and perform case follow-ups as needed
Support Quality documents review / control.

Requirements:

Bachelor degree or above in related scientific discipline
Minimum 2 years of relevant experience in pharmaceutical or medical device industry
Ability to work independent with a great team play spirit and well organized
Fluency in spoken and written English, Cantonese and Mandarin.

What we offer:

Support for Parents
Continuing Education/ Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer.

Additional Information:

Job Posted:

March 21, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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