General Electric Qualified Person - MI China in Shanghai, China
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To perform Qualified Person batch release activities for PET radiopharmaceutical medicinal products manufactured by external contract manufacturing organizations on behalf of GEHC in China.
Act as PDx Molecular Imaging QA contact in support of PDx Molecular Imaging business China initiatives.
Essential Responsibilities :
-responsible for the development and maintenance of the GEHC Quality Management System to support the GEHC manufacturing authorization in relation to the oversight of a Contract Manufacturing Organization (CMO) in China.
-Perform routine audits of Chinese PET CMO manufacturing sites to ensure compliance to GMP, product marketing authorization and quality assurance agreements.
-Participate in the quality management activities such as the establishment of the organization quality management system, internal self-inspection, external quality audit, verification, adverse drug reaction reports, product recalls, etc.;ãã
-Undertake the responsibility of product release and ensure that the production and inspection of each batch of released products comply with relevant laws and regulations, drug registration requirements and quality standards;
-Before the product is released, the Qualified Person must issue a product released review record in accordance with the requirements of the item above and include it in the batch record.
-Ensuring systems are in place to assure Quality activities are carried out in compliance with product license commitments, cGMP and company Quality standards
-Fostering an environment of continuous improvement
-Liaison with external regulatory bodies
-Creation, revision and approval of quality management system procedures
-Support in the authoring and approval of relevant quality sections of marketing authorization applications and variations
PRINCIPAL QUALIFICATIONS REQUIRED:
The qualified person should have at least a bachelor degree in pharmacy or related majors (nuclear related majors preferred) (or intermediate professional technical titles or licensed pharmacist qualifications), have at least five years of practical experience in drug production and quality management, and have engaged in drug production process control and quality inspection.
China Qualified Person working experience is essential.
WORK EXPERIENCE REQUIRED:
Have at least five years of practical experience in radiopharmaceutical drug production and quality management, and have engaged in drug production process control and quality inspection.
It is highly desirable that this experience be in the area of radiopharmaceuticals.
ATTRIBUTES AND SKILLS
Able to communicate effectively with the relevant internal and external stakeholders, have very good written and oral Chinese skills. Ideally have a very good knowledge of English.
Able to perform business trips and are willing to travel (approx. 30%)
Desired Characteristics :
Additional Eligibility Qualifications :
Relocation Assistance Provided: Yes