About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: To assure activities that are related to Good Manufacturing Practice (GMP) operations in compliance with cGMP requirements and drug regulations. To establish Quality Management System (QMS) and build Quality culture for the Guangzhou Site (GZS), and extend it to routine operations after closure of project.
Essential Responsibilities: 1. Manage the Quality Function in order to provide accurate, compliant and timely support to the project especially with regards to ensuring that activities are in alignment with multi-discipline cGMP to enable future site operations in compliance with drug regulations. 2. Cooperate with global team and other functional teams on GZS to establish the QMS that is lean, effective and compliant so that all quality related activities and documentations are stipulated under the QMS during project period and future routine operations. 3. Lead, train, motivate and manage the performance of the Quality team. 4. Guide functional team to complete protocols, reports and SOPs etc, and authorize all GxP related documents in line with cGxP requirements. 5. Prepare budget for Quality function and activities – human resources, overheads and validation. 6. Anticipate and plan for future requirements in the area, including but not limited to, procedural requirements, capital equipment planning, personnel recruitment planning, compliance requirements, efficiency developments and potential changes; reflect future demand for services from the function, and consequently build them in a timely manner in the budgeting process. 7. Set up challenging goals in Quality function and work towards them jointly with Quality team and stakeholders; report and check status regularly to keep the set targets reasonable and attainable. 8. Foster an environment of continuous improvement. 9. Liaison with external regulatory bodies to remain GZS upfront with compliance requirements and regulations.
Qualifications/Requirements: 1. Bachelor in Sciences as minimum, post-graduate degree and above is preferable. 2. Familiar with multi-disciplines GMP and drug regulations. 3. Good communicator, collaborative and decisive as a team leader. 4. Skillful in both written and oral English. 6. Minimum 6 years supervisory\\management experience in Bio-pharmaceutical or Pharmaceutical Industry essential. 7. Quality working experience in Bio-pharmaceutical is preferable.
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