職位描述
Responsibilities * Participate in the design and implementation of CD, BD, DD of engineering projects, ensure that GMP requirements and compliance requirements of relevant regulations are implemented in the design and implementation of projects, and support the corresponding risk assessment. * To ensure effective processes and controls, in the establishment of facilities and equipment validation plan, validation and relevant GMP documents, to ensure that meet AZ standards * Evaluate and approve product technical transfer documents * Transfer quality related knowledge with the sending site, and establish relevant route quality processes, to support process validation and commercial manufacture readiness * Ensure that the assessment of changes within the scope of the project, the investigation and handling of deviations or exceptions are in line with AZ quality management requirements. * Ensure the effective evaluation of related processes within the scope of the project, review and approve GMP related documents, and ensure that which comply with AZ standards. * The implementation of effective processes and control measures to ensure the integrity of project related documents and ensure that they meet AZ standards * Coordinate the resources of relevant internal quality teams to ensure the assessment of quality SMEs in relevant fields, the conformity of the quality of registration documents and the participation in internal and external audits as the main quality representative * Cooperate with the sending site to promote continuous improvement of product processes and ensure compliance with regulations. * Eliminate non-value added activity in quality process of projects through lean tools to keep continuous improvementRequirement * Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry. * 5+ years prior experience as quality professional or other equivalence experience in engineering and product transfer project including area of Engineering design, validation strategy of Utility/Facility and equipment, Technical transfer, Process validation and clean validation and quality compliance. * and understanding of the principles and concepts of compliance to regulation and Good Manufacturing Practices. * Overall GMP/GDP and related regulation knowledge. * Promoting effective problem-solving using a risk-based approach * Making bold, rapid and timely decisions with energy, urgency and accountability * Good command of English
