• 招聘类型：社招
• 工作性质：全职
• 所属区域：北京 - CBD
• 直属部门：QA

职位描述

Responsible for management of Quality System to ensure compliance with company standards, cGMP, regulatory requirements, applicable where clinical trials are conducted, or for the markets where products are sold. This includes CFDA, USFDA, and other relevant competent authorities in EU as well as applicable international quality standards.Partner with the leaders and team members of BeiGene Global Quality organization to establish quality practices that are clear and efficient and consistent globally.Interface with CFDA and other regulatory agencies during site inspections; responsible for ensuring timely execution of corrective actions.Responsible for ensuring manufacturing site is inspection ready.Responsible for the release (or rejection) of API, drug product (commercial and clinical) .Partner with CMC and manufacturing team to establish consistent processes ensuring quality standards and GMP compliance .Responsible for approving procedures, analytical methods, product specifications, master batch records, raw material and API specifications, validation documents, reports for process, cleaning, equipment, analytical methods, shipping, and computerized system.Responsible for product quality control and oversight for distribution of Partner’s marketed products; ensuring compliance with Quality Agreement.Maintain a culture of quality in line with global business strategy .Establish key performance indicators (KPI) for the quality system .Provide periodic reporting on the performance of the Quality System which include metrics, performance monitoring and action plans

任职条件

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要