Onsite Technician Site Services

Main responsibilities职责描述

• As a QualiPSO CMS Business Owner 作为QualiPSO 系统CMS 流程专家

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• Oversee the local implementation and management of the QualiPSO Clinical Management System (CMS).

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• Ensure the CMS meets local business needs while aligning with global standards and processes.

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• Evaluate the impact of system changes or updates on local processes and users.

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• Collaborate with the global QualiPSO team to implement new features or updates.

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• Provide guidance and support to local users on QualiPSO CMS operations and best practices.

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• Coordinate and deliver training sessions for new users and refresher courses for existing users.

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• Oversee the local document control processes within QualiPSO CMS.

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• As a Document Management Specialist ensure compliance with document management standards and regulatory requirements. The main responsibilities include ensuring local document compliance continuous improvement of document formats and content management and ensuring 100% in place in use of GAP analysis for documents at the local level.

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• Act as the primary point of contact for QualiPSO CMS matters at the local level. Liaise between local users IT support and the global QualiPSO team.

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• Manage local user access rights and permissions within QualiPSO CMS.

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• Ensure proper implementation of role-based access control (RBAC) for data security.

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• Generate and analyze reports on CMS usage document statuses and other relevant metrics.

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• Provide insights to local management on document management performance and trends.

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• Ensure QualiPSO CMS processes comply with local and global regulatory requirements.

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• Support internal and external audits related to document management and control.

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• Stay updated on QualiPSO CMS features and best practices.

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• Propose and implement process improvements and system enhancements.

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• Act as the first point of escalation for local QualiPSO CMS issues.

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• Collaborate with IT support and the global QualiPSO team to resolve complex problems.

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• Maintain and update local QualiPSO CMS documentation including job aids and standard operating procedures.

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• Contribute to the QualiPSO knowledge base and share best practices with the wider community.

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• As a Deviation & CAPA Business Owner 作为本地偏差&CAPA 流程专家

Deviation Management 偏差管理

• Lead the identification investiga tion and resolution of deviations in local processes.

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• Utilize QualiPSO to create manage and track deviations.

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• Ensure compliance with Sanofis global quality standards and regulatory requirements.

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  CAPA Implementation 纠正和预防措施CAPA实施

  Develop and oversee Corrective and Preventive Action (CAPA) plans.

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  Coordinate cross-functional teams to implement CAPA measures effectively.

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  Monitor CAPA progress and ensure timely closure of actions.

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  QualiPSO System Expertise

  Serve as the local expert for & CAPA.

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  Provide guidance on deviation and CAPA processes to team members and stakeholders.

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  Ensure proper documentation and traceability of quality events.

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  Process Improvement 流程改进

  Analyze trends in deviations and CAPAs to identify areas for process improvement.

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  Develop and implement strategies to prevent recurrence of quality issues.

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  Contribute to the continuous improvement of local quality management processes.

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  Training and Support 培训和支持

  Conduct training sessions on deviation management and CAPA processes.

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  Offer support and mentorship to team members on quality-related activities.

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  Stay updated on changes in quality procedures and communicate updates to relevant parties.

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  Compliance and Reporting 合规和报告

  Ensure local deviation and CAPA processes align with Sanofis global standards and regulatory requirements.

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  Prepare and present quality metrics and reports to management.

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  Participate in audits and inspections related to deviation and CAPA processes.

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  Collaboration and Communication 协作与沟通

  Liaise with global quality teams to ensure alignment of local processes with corporate standards.

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  Collaborate with cross-functional teams to address quality issues effectively.

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  Communicate quality-related information clearly to various levels of the organization.

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  As a quality transformation coordinator 作为质量变革协调员

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  Coordinate and oversee quality transformation projects across different departments and functions

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  Practice management efforts related to quality transformation initiatives

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  Support managers and employees in adapting to new quality processes and systems

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  Identify opportunities for quality process improvements and efficiency gains

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  Collaborate with cross-functional teams to streamline quality-related workflows

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  Support the digitalization of quality management systems and processes

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  Coordinate the implementation of new quality-related technologies and tools

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  Ensure data integrity and compliance in digital quality management systems

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  As a QualiPSO BSO & User management administrator作为QualiPSO系统本地系统及权限管理员

  User Management 用户权限管理

  Administer user accounts roles and permissions within QualiPSO for local users

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  Process and approve access requests for various QualiPSO modules (e.g. Deviation/CAPA Content Management Third Party Risk Management)

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  Ensure appropriate access levels are granted based on user roles and responsibilities

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  According to the requirements of the Global group and regulations conduct regular reviews of system permissions

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  Training and Support 培训支持

  Provide first-level support for user queries and issues related to QualiPSO

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  Ensure proper configuration and use of these modules according to Sanofis global standards

  确保按照赛诺菲全球标准正确配置和使用这些模块

  Change Management

  Communicate system changes and updates to local users

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  Continuous Improvement 持续改进

  Stay updated on QualiPSO developments and new features

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  Propose and implement improvements to local QualiPSO processes

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  Participate in global QualiPSO user communities to share best practices and learn from other sites

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  Artwork & Shade Card management Artwork包装设计及封样卡管理

  Artwork Quality Approval 包装设计质量批准

  Review and approve packaging artwork ensuring compliance with Sanofis global standards and local regulatory requirements

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  Shade Card Management 封样卡管理

  Oversee the development and maintenance of shade cards for product packaging

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  Ensure color consistency across different batches and production runs

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  Collaborate with suppliers to maintain color standards and quality

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  Correctly utilize the Globalvision inspection software to complete the inspection of new version shade cards and generate inspection reports.

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  Based on the inspection results carry out the approval distribution retrieval and destruction of the proof cards.

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  Quality Department HSE Responsibilities质量部HSE职责

  Incorporate HSE work into the work plan

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  Actively cooperate with HSE management to prevent accidents happens.

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  HSE8 requirements. Feedback HSE issues in a timely and accurate manner and actively implement remediation.

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  Participate in the investigation for accidents analyze the root causes of accidents from the quality management perspective and related CAPA.

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  Sanofi (Beijing) Pharmaceutical Co. Ltd. Energy Policy: Quality as the top priority through technical behavioral human consciousness continuously reduce the rate of energy consumption in product value benefit the users and promote company development. Good awareness of energy conservation is required participate in energy saving actions and assist in the continuous development of the energy management system.

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  Actively propose energy-saving projects

  积极提出节能方案

  Coordinate and support the development of energy-saving projects and give positive feedback

  协调并支持节能项目的制定积极反馈意见

  Coordinate and participate in the implementation of energy-saving projects

  协调并参与节能项目的执行

  Participate in internal audit of energy management system

  参与能源管理体系的内部评审

• About you 任职资格:

  List here ideally the must-haves criteria to be successful on the role.

  请列出胜任该职位所必须具备的条件

  Experience: At list with minimum 5 years experience in pharmaceutical production and /or quality assurance.

  工作经验:至少5年药品生产或质量保证工作经验

  Soft skill: Good communication and collaboration.

  通用技能: 良好的沟通与合作能力

  Technical skill: Must be a committed quality professional with knowledge of regualed quality systems within the pharmaceutical or related industry.

  专业技能: 必须具备制药或相关行业的质量体系的质量专业知识经验

  Education: At least a bachelor degree in pharmacy or chemistry or biology disciplines or Licensed Pharmacist qualification

  教育背景:至少药学或化学或生物学或相关专业大学本科学历(或执业药师资格)

  Languages: Fluent English in verbal & written.

  语言要求: 熟练的英语书写及沟通能力

  Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi

  全力致胜行为: 超越自我 主动出击 以患者和客户为本 团结一致

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor

Dare to go further in your career. Join our global team of 14000 associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes peoples lives for the better. It brings new patient treatments and therapies to market giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his moms voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

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