Quality Assurance Specialist

Job description

3199720
Additional Cities

Hong Kong
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

Hong Kong
Role Summary/Purpose

This position involves working within the QA department to facilitate the carrying out of QA activities and to ensure compliance with current regulations and industry practices.
Essential Responsibilities

• Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations
• Supporting the ongoing deviation / corrective action program
• Liaising with other departments to allow closure of corrective actions
• Conducting audits, together with follow up.
• Supporting regulatory inspection-readiness, including leading or participating regulatory inspections as the PIC (person in charge)
• Responding to routine quality related queries from other departments
• Monitoring and aiding the implementation of continuous improvements and process changes to ensure that these are implemented in compliance with GDP.
• Training of Operations personnel and deputy PIC
• Attending a number of cross functional team meetings / projects
• Support the timely release of product to market.
• Conducting QA activities including revision of SOPs, QA work and the issuance of protocols.
• Review, Approval and Reporting Activities related to the QMS Quality Specific Goals:
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management
• Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Zero repeat findings from previous internal and external audits within area of responsibility.
• 5.100% on time CAPA closure for corrective action investigations
Qualifications/Requirements

• B.S. Degree in business or technical field or equivalent experience
• 1-2 year experience in pharmaceutical industry.
• 1-2 year experience with CA/PA systems, including complaint handling.
• Thorough familiarity with GDP of pharmaceuticals.
• Knowledge of relevant Electronic Management Systems transactions and familiarity with Excel / Word packages

Preferred Qualifications: 1. Statistics education and or training 2. Experience developing and tracking quality metrics 3. Familiar with Continuous Improvement methodologies, including Six Sigma
About Us

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com
Primary Country

Hong Kong
Primary City

Hong Kong