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3-4年经验 -
硕士 -
招1人 -
12-13 发布
职位描述
职位描述： Location: Shanghai or Suzhou, ChinaPOSITION SUMMARY:Support on Quality Oversight at External Manufacturing site (Scheduled visits) and maintain oversight for external manufacturer’s quality systems as they relate to Zoetis Drug Products, APIs and other Animal Health related products, and ensure compliance with GMP / regulatory expectations.POSITION RESPONSIBILITIES：1.Supplier/Contractor Management: Ensure suppliers/contractors have applicable quality systems and comply with GMP/regulatory requirements and Zoetis expectations for the product. Oversee GMP activities at suppliers/contractors, such as Change Control, Deviation Management, Lot Approval, Complaint Handling, Annual Product Reviews (APR), Stability Study, Validation Approval, Audit Support, Quality System Support and Metrics Review, etc.2.New Product Introduction (NPI): Support the selection, audit and evaluation of potential contractors in the process of NPI. Assess the quality and compliance status at contractors prior to sourcing decision. Carry out due diligence Quality audits as directed and make recommendations on suitability of contractors and new business opportunities.3.Product Transfers: Act as QA support to Product transfer teams and advise such teams on Zoetis expectation regarding process validation and Analytical Method Transfer Exercise (AMTE) performed at contractor. Supply QA approvals as required of the Transfer Plan and other activities, eg. Validation.4.Regulatory: Support or conduct Regulatory compliance assessment at contractor. Support the process of documentation retrieval and collation to support Manufacturing Authorization renewals. Assess risk for Annual Reportable changes and CBE’s and communicate/approve risk assessments when required. Act as QA focal point for regulatory communications and changes.5.Contract Process: Support the Supply Agreement contract process by developing, negotiating the Quality Agreement and co-ordinate the quality document agreement and approval route ensuring all key quality requirements are met. Maintain established Quality Agreements with contractors.6.Other Contractor Assessments/Regulatory Inspections and Interactions: Facilitate and participate in assessment programs of contractors. Act as the Zoetis representative in the event of an external regulatory inspection involving Zoetis product at the contractor. Support contractor to develop and implement audit action plans, and track contractor CAPA plans to completion.7.Development and Implementation of ESQA Guidelines & Policies: Contribute to the maintenance of the ESQA Quality System. Participate in developing ESQA Guidelines to ensure consistency of contractor standards across Zoetis. Ensure a consistent approach to the interpretation and implementation of GMP standards and Zoetis expectations.ORGANIZATIONAL RELATIONSHIPS:External Supply Quality Assurance, External Supply, Procurement, Veterinary Medicine Research and Development, Sites, Global Technology Services, Business Development, Supply Chain & Logistics, Global Quality, Affileate QualityTECHNICAL SKILL REQUIREMENTS:1.Level of Education: M.Sc., B. Pharm, M. Pharm or equivalent degree2.Experience: Minimum 3-5 years of relevant pharmaceutical industry experience in QA and/or Manufacturing3.Languages: Fluency in English, Any other language is an asset4.Computer skills: Advanced user-level of MS Office applications5.Profile: Ideal candidates should possess the following skills or have experience in the following:?Experience that may include multifunctional, multi-site or other functional experience?Working with multicultural, cross-functional work teams?Experience in Quality Compliance functions?Working knowledge of Quality Systems and Risk Management?Knowledge of US FDA / EU GMP requirements impacting manufacturing operations?Ability to work independently and in teams 职能类别： 生物工程/生物制药 关键字： Manager China External Supply Quality Assurance
联系方式
上海市长宁区江苏路398号舜元企业发展大厦A座15层
公司信息
硕腾，原为辉瑞的动物保健部门，作为一家全球领先的动物保健公司，致力于为客户及其业务提供最有力的支持。秉承60年的悠久历史，我们为用户提供优质的兽药和疫苗、业务支持和技术培训。在《福布斯》“2017年美国***雇主（中型企业）”中硕腾公司也有幸入选，这是硕腾公司第二年入选，排名在Top300中列114位。这份殊荣是对硕腾的工作环境、公司文化和企业品牌的认可。我们将继续不懈努力，帮助饲养和关爱动物的人们，为他们解决所面临的各种挑战。我们的英文名字Zoetis (zō-EH-tis)，其词根为zo，以 zoo（动物园）和zoology（动物学）而广为人知。Zoetis源于zoetic（有生命的，有生气的），蕴含“赋予生命的意义”之义。硕腾（Zoetis）致力于为世界各地的饲养和关爱动物的兽医和畜牧从业人员提供支持。
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