OQA Manager

    • Yangcun, China

Site Name: China - Tianjin - DongLi District - No.270 Chenglin Road
Posted Date: Dec 19 2019
Job Purpose 岗位目的:

  • To lead a team of QA Specialists in ensuring that an effective Operational Quality service is provided to the site.领导QA专员团队为工厂提供有效的运作质量服务。
  • To ensure that products for sale have been manufactured and packaged in accordance with the licensing requirements, GMP, Medical Device and business requirements, and to promote quality/compliance within the Value Streams.保证产品在生产和包装过程符合注册标准,GMP和医疗器械法规的要求以及商业需求,并且推动价值流内的质量符合性。

    Key Responsibilities主要岗位职责:
  • Supervise implementation of GMP, Medical Device, SOP and safety policy; ensure it meet national and GSKstandards.
    监督GMP、医疗器械法规、SOP及安全环保政策的执行达到国家和GSK的标准。
  • Accountable for functional risk management, includes proactive risk identification, assessment and mitigation plan development.确保所在部门风险管理体系的有效性,包括积极主动对风险进行识别、评估和制定缓解行动计划
  • Participate quality system set up, internal audit, external audit, validation and AE report, product recall etc quality management activity.参与企业质量体系建立、内部自检、外部质量审计、验证以及不良反应报告、产品召回等质量管理活动;
  • Provide leadership and technical support for all GMP/quality activities for value streams and other assigned areas of responsibility.对于所有有关GMP和质量活动对价值流和相关区域提供领导和技术支持。
  • Responsible for ensuring that product quality issues are correctly investigated and that appropriate corrective and preventative actions are implemented.有责任确保产品质量问题被正确地调查,合适的纠正预防行动已实施。
  • Rectifying or reporting on any deviations from GMP or the Quality Management System.纠正或汇报任何与GMP和质量管理系统的偏差。
  • Providing advice to line management to ensure that GMP compliance requirements are built into the site'score practices.
    为生产线管理提供建议,以保证GMP符合性已建立在所有核心流程中。
  • Co-ordinate, assess, investigate and approve product/process quality investigations (e.g. unplanned change, customer complaints, etc).协调,评估,调查和批准与产品和工艺相关的调查。(例如非计划的变化,客户反馈等)
  • Provide GMP advice to production area. Act as quality coach and mentor to value streams through alignment, proactive involvement in quality improvement and inspection readiness activities and focusing on prevention activities in support of achieving business objectives;
对生产区域提供GMP的指导。 作为质量指导和顾问对价值流进行支持,通过协
同和主动的质量改进活动,审计,关注预防措施以支持公司商业目标的达成。
  • Deliver GMP and QMS training.
提供GMP和QMS培训。
  • Approve and monitor all quality related systems, procedures and documentation utilized within value streams批准和监督所有在价值流中质量相关的系统,流程和文件
  • Responsible for OQ team development, improve team engagement负责OQ团队人员的发展计划,持续发展员工技能,提高团队人员的工作积极性和敬业度。
  • Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.理解并遵守适用的质量、环境、健康及安全等方面的当地法律法规、葛兰素质量管理体系及环境健康安全等方面的标准和公司方针,遵守公司标准操作规程。
  • Other projects and tasks as assigned by the line manager.
其它由直线经理安排的项目和工作。

Why you? Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

  • 文化程度(学历/专业) Degree大学本科药学或相关专业毕业;(或中级专业技术职称或执业药师资格)
    Bachelor, Pharmacy or related. (or have Pharmaceutical Engineering certification or certified pharmacy)
  • 任职经验Experiences具有至少五年从事药品生产和质量管理的实践经验,从事过药品生产过程控制和质量检验工作。或经
    过工厂评估具备相应知识和资质的培训.
    More than 5 years experiences of production and quality management. Have experience of quality control and quality assurance. Or equipped with equivalent knowledge and kill assessed by site. (e.g. sufficient training)
  • 专业知识/技能 Technical talent熟悉相关国家和地方质量政策法规(GMP,药监,药检等)
    Familiar with relevant National and local quality regulation.( GMP, SFDA, IDC)
    具备药品验证理论知识和经验,熟悉质量管理工具的应用
    Familiar with validation theory and experience and the quality tools implementation.
    具有质检或相关证书 Certificate of QA
  • 计算机及外语水平 Computer and English level电脑及业务软件的使用能力 Familiar with the Office software and other professional software.
    英语水平较好(会话、阅读相当于6级) English level CET-6 for oral and reading ability.
  • 能力要求 Professional
良好的职业道德,诚信、正直、认真、坚持原则 Well occupational moral, Honest,
persist in the principles.
高度的质量敏感性 High sensitivity of Quality
较强的沟通、协调,组织,领导,创新能力 High ability of communication,
coordination, leading and creation.
较强的分析判断解决问题能力 Good ability of analysis and judgement.
较好的书面报告能力,较强的学习能力 Good ability of report and learning.
Why GSK?
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

This is a job description to aide in the job posting, but does not include all job evaluation details.
LI-GSK

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