Document Control and Training Specialist - Beijing
百济神州(北京)生物科技有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-11-28
- 工作地点:北京
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:招1人
- 语言要求:不限
- 职位类别:生物工程/生物制药
职位描述
-Manage and maintain controlled documents in Veeva Vault QualityDocs (VVQD) including creating draft documents, maintaining profile card metadata, and linking supporting documents
-Track Document Change Requests and Document Change Controls within VVQD to ensure reviews and approval are completed within strict timelines
-Coordinate the review, approval, and archival of BeiGene’s controlled documents in accordance with GxP regulations
-Edit and proofread controlled documents for formatting, legibility, completeness, and adherence to Quality templates and procedures
-Implement and utilize advanced word processing and automation features of Microsoft Office software
-Build and Run reports in Veeva Vault QualityDocs to ensure accuracy and completeness of the document control process
-Participate in validation testing for system implementations and updates
-Manage Document Control email inbox with prompt responses to internal customers
-Create learning content such as pre-recorded videos, PowerPoint presentation, and other classroom-style trainings.
-Build and maintain items in the LMS such as training items, curricula, user groups, quizzes, SmartForms and assignments
-Provide training to LMS and VVQD customers/users as needed on variety of technical and quality related topics
-Other duties as assigned
职位要求:
-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.
-Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
-Project Management - Communicates changes and progress; Completes projects on time and budget.
-Track Document Change Requests and Document Change Controls within VVQD to ensure reviews and approval are completed within strict timelines
-Coordinate the review, approval, and archival of BeiGene’s controlled documents in accordance with GxP regulations
-Edit and proofread controlled documents for formatting, legibility, completeness, and adherence to Quality templates and procedures
-Implement and utilize advanced word processing and automation features of Microsoft Office software
-Build and Run reports in Veeva Vault QualityDocs to ensure accuracy and completeness of the document control process
-Participate in validation testing for system implementations and updates
-Manage Document Control email inbox with prompt responses to internal customers
-Create learning content such as pre-recorded videos, PowerPoint presentation, and other classroom-style trainings.
-Build and maintain items in the LMS such as training items, curricula, user groups, quizzes, SmartForms and assignments
-Provide training to LMS and VVQD customers/users as needed on variety of technical and quality related topics
-Other duties as assigned
职位要求:
-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.
-Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
-Project Management - Communicates changes and progress; Completes projects on time and budget.
职能类别:生物工程/生物制药
公司介绍
百济神州是一家立足于科学的全球性生物科技公司,专注于开发创新、可负担的药物,旨在为全球患者改善治疗效果,提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作,加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。
联系方式
- Email:shan.liu@beigene.com
- 公司地址:昌平区生命科学园 (邮编:102206)