IT管理员 - 质量管理系统
IT Administrator- Quality management System
在QMS主管和企业质量保证领导的指导下，质量管理系统专员将负责 AmerisourceBergen 质量管理系统（QMS）的日常支持和开发需求。质量系统专员将与IT部门合作，创建和维护QMS流程，以满足QA部门的需求，并管理整个组织中QMS的有效性和标准化。这包括记录最佳实践、识别流程低效之处，并确保QA流程与公司战略和政策保持一致。
质量系统专员将负责生成报告、收集指标，并接收业务需求以进行改进、扩展，并执行复杂的流程导向项目。
其他职责包括根据用户报告的问题进行故障排除，支持对eQMS服务的Web访问，并维护安全的系统环境。他们还将根据应用需求和预期增长，与eQMS供应商协同推进基础设施扩展，并与项目经理合作协调和规划项目任务和资源。
主要职责和责任：
- 在eQMS中管理受控文件（政策、SOP、WI和表格），并确保其符合公司和/或监管要求。
- 与QA管理团队其他成员合作，根据需要开发/修订和实施QA政策和程序。可能担任文件作者、审核者和/或批准者的角色。
- 作为受控文件的eQMS次级（备用）管理员，负责文件分配培训、资料更新、保险箱创建、文件过期等。
- 按需支持质量系统流程的培训。
- 按需协助EQA团队进行内部审核、受控文件审查等。
- 提供关于CAPA流程的支持和咨询，包括CAPA接收流程和表单（如偏差、不符合项、投诉、审核等）。
- 跟进并提供与受控文件、CAPA和持续质量改进相关的关键绩效质量指标所需数据。
- 根据识别的趋势和关键绩效质量指标，推荐组织流程改进方案。
- 维护质量系统活动的状态报告，并按计划/要求提供给相关方。
查看英文原文
Under direction of the QMS Lead Admin and Enterprise Quality Assurance Leadership the Quality Management System Specialist will be responsible for the day to day support and development needs for AmerisourceBergens Quality Management System (QMS). The Quality Systems Specialist will partner with IT to create and maintain QMS processes to meet the needs of QA departments and manage effectiveness and standardization of the QMS across the organization. This includes the capability to document best practices, identify process inefficiencies, and ensure alignment of QA processes with corporate strategy and policy.
The Quality Systems Specialist will be responsible for producing reporting, gathering metrics, and intaking business requirements for enhancements, add-ons, and executing on complex process-oriented projects.
Other responsibilities include troubleshooting problems as reported by users, supporting Web access to eQMS services and maintaining a secure systems environment. They will also facilitate infrastructure expansion in tandem with the eQMS vendor, based on application needs and anticipated growth andwork with project managers to coordinate and plan project tasks and resources.
PRIMARY DUTIES AND RESPONSIBILITIES:
- Manage the controlled documents (Policies, SOPs, WIs and Forms) in the eQMS and maintain them in compliance with corporate and/or regulatory requirements.
- Work with the rest of the QA management team in the development/revision and implementation of QA policies and procedures as required. May perform the roles of document Author, Reviewer, and/or Approver.
- Serve as the secondary (back-up) administrator of the eQMS for controlled documents, assignment of training, profile updates, vault creation, obsolescence of documents, etc.
- Support training for Quality Systems processes as needed.
- Assist the EQA team with performing internal audits, reviews of controlled documents, etc. as required.
- Provide support and consultation on the CAPA process, including the CAPA-intake processes and forms (such as deviations, non-conformances, complaints, audits, etc.).
- Follow-up and provide data required for key performance quality metrics related to controlled documents, CAPAs and continuous quality improvements.
- Recommend organizational process improvement initiatives based on identified trends and key performance quality metrics.
- Maintain status reports for quality systems activities and provide to stakeholders as scheduled/requested.
- Support the Business Process Owners (BPOs) in providing technical, procedural, and compliance-based guidance to eQMS users as needed.
- Provide support during regulatory inspections by Health Canada and during quality audits by customers and third party auditors.
- Provide assistance to the QA Managers and QA Director as required.
- Work under challenging deadlines and be accountable for completing work within specified time periods.
- Works closely with IT / QA to manage risk, verification, quality, and validation plans.
What your background should look like
- Bachelors degree or technical institute degree/certificate or equivalent work experience.
- Typically requires a minimum of three (3) years of relevant experience deploying and/or administrating Quality Management solutions
- Relevant certification is preferred
- Requires strong knowledge and experience with multiple infrastructure solutions.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
- Ability to work cross functionally to develop and maintain QMS system, documentation, and regulatory requirements
- Proficiency in the use of computerized systems to effectively administer the specialized electronic quality management system (eQMS) applications, as well as efficiently utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel, Visio and Adobe Acrobat).
- Strong organization skills
- Good analytical and problem solving skills.
- Ability to communicate effectively both orally and in writing
- Good interpersonal skills; solid team player
- Exceptional customer service skills
- Good group presentation skills
- Ability to lead tech
- Originally posted on Himalayas