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 system qualification and validation in compliance with Current Good Manufacturing Practice (cGMP) and Good Automated Manufacturing Practice (GAMP) requirements and standards. To establish Validation System for the Guangzhou Site (GZS), and extend it to routine operations after closure of project.
Essential Responsibilities: Manage the Validation 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-disciplines in cGxP and Environment, Health, Safety (EHS) to enable future site operations in compliance with applicable regulations and laws. Cooperate with global team and other functional teams on GZS to establish Validation System which is lean, effective and compliant, so that all Validation related activities and documentations are adhering to cGxP disciplines during project period and future routine operations. Lead, train, motivate and manage the performance of Validation team. Guide functional team to complete protocols, reports and SOPs etc, and prepare and approve all validation related documents in line with cGxP requirements. Responsible for co-ordinating all validation activities on the site, and make all validation work properly documented and archived. Ensure Validation Master Plan, Validation Plans, and Validation Maintenance Plans be in place operationable and traceable and approved by appropriate responsible persons in the organization. Manage and supervise consultants and contractors on validation work. Prepare budget for Validation function and activities – human resources, overheads and equipment. 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. Set up challenging goals in Validation function and work towards them jointly with cross functional teams; report and check status regularly to keep the set targets reasonable and attainable. Foster an environment of continuous improvement.
Qualifications/Requirements: Bachelor in Sciences as minimum, post-graduate degree and above is preferable. Familiar with multi-disciplines GMP and GEP and relevant drug regulations. Good communicator, collaborative and decisive as a team leader. Skilful in both written and oral English. Minimum 5 years supervisory\\management experience in validation of Biopharmaceutical or Pharmaceutical Industry essential. Validation working experience in Biopharmaceutical industry is preferable.
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