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Head of Quality Validation, Top Pharmaceutical Company

Job Title: Head of Quality Validation, Top Pharmaceutical Company
Contract Type: Permanent
Location: Shanghai, China
Industry:
Salary: Negotiable
Reference: RY2002254_1510554706
Contact Name: Cherry Zhu
Contact Email: czhu@profileasia.com
Job Published: November 13, 2017 14:31

Job Description

Primary Purpose of Job (Job Summary) 主要工作目标(岗位简介)

  • Ensure an effective site qualification and validation program is developed, implemented and maintained, including periodic reviews, requalification and revalidation.

确保建立、实施和维护有效的场地确认和验证程序,包括周期性回顾、再确认和再验证。

  • Allocate, administer and manage resources to perform Quality Qualification, Validation and CSV

分配、执行和管理资源以执行质量确认、验证和CSV活动。

  • Engage in and provide leadership for corporate activities to address complex qualification and validation approaches and issues and support operational units at plant.

积极参与企业活动并提供领导,以解决复杂的确认和验证的策略和问题,并支持工厂的运营单位。

  • Ensure operational and laboratory areas (including processes and utilities) are qualified and validated according to current GMPs.

根据现行GMP,确保运营和实验室区域(包括工艺和公用工程)处于已确认和已验证状态。

  • Ensure that a list of all current qualified and validated systems, processes and computerized systems is maintained and procedures reflect current HA requirements.

确保记录所有当前已确认和已验证的系统、工艺和计算机系统的列表的维护,并且该程序反映当前HA的要求。

Principle Roles & Responsibilities / Accountabilities 主要职责/责任

Technical and Functional技术和功能:

  • Ensure GMP requirements are met for qualification and validation of manufacturing and laboratory equipment, buildings, utilities, computer systems, etc.

确保生产和实验室设备、建筑物、公用工程、计算机系统等的确认和验证符合GMP要求。

  • Review and approve qualification and validation documents.

审核和批准确认和验证文件。

  • Update Validation Master Plan. Perform periodic reviews of equipment qualification and maintenance status, validation status and maintenance of the computer validation master plan.

更新验证主计划。对设备确认和维护、验证状态进行周期性回顾,对计算机验证总计划进行维护。

  • Qualification, Validation and Q-CSV expert for systems and projects, including

系统和项目的确认、验证和Q-CSV专家,包括IT。

  • Participate in Local Change Management process as change owner and/or change controller (where applicable).

作为变更所有人和/或变更控制人参与本地变更管理流程(如适用)。

  • Quality Owner responsible for discrepancies for qualification, validation relevant topics.

负责确认、验证相关主题差异的质量负责人。

  • Professional review and, if necessary, approval of SOPs and other GMP relevant documents of the respective area of responsibility.

专业审核,如有必要,批准SOP和相关责任区域的其他GMP相关文件。

  • Participate in self-inspections and support regulatory inspections and partner audits.

参与内审,支持监管检查和合作伙伴审计。

  • Assessment and implementation of Quality Requirements and Global Standards & Procedures.

质量要求和全球标准与程序的评估与实施。

  • Ensure senior site leadership is regularly updated on significant qualification and validation issues.

确保定期向场地高级领导层报告重大确认和验证问题。

  • Represent the QU in planning of larger investment projects (where applicable).

代表质量部参与规模较大的投资项目(如适用)。

Education/Qualifications教育程度/所获资格证书

  • Bachelor's Degree required (Pharmacy, Pharmaceutical, Bioengineering, Chemistry or other relevant area preferred. Depending on local )

学士学业(药学、制药、生物工程、化学或相关领域优先。 取决于当地法律)。

  • Graduate or higher-level Degree is preferred

更高学位或在读优先。

  • 7 or more years' work experience in the pharmaceutical field of engineering, construction or qualification

制药行业工程、建筑或确认领域7年以上工作经验。

  • 4 or more years' people management experience 4年以上人员管理经验。
  • 3 or more years' experience in the validation of pharmaceutical manufacturing facilities, equipment and computers 3年以上药品生产设施、设备和计算机验证。

Job Required Competencies岗位所需胜任力

  • Strong knowledge of Quality System principles, practices and standards for the pharmaceutical industry

制药行业质量体系原则、规范和标准的丰富知识。

  • Expert knowledge of cGMP relevant to the pharmaceutical industry

与制药业相关的cGMP专家知识

  • Strong knowledge in implementation, qualification and validation of procedures for quality control of active ingredients and excipients

活性成分和赋形剂的质量控制程序的实施、确认和验证的丰富知识。

  • Strong knowledge of QS Systems (GMP, ISO, CFDA, FDA, AMG, AMWHV) QS体系的丰富知识(GMP, ISO, CFDA, FDA, AMG, AMWHV)。
  • Strong knowledge in CS validation pursuant to GAMP5

根据GAMP5执行CS验证的丰富知识

  • Demonstrate excellent verbal and written communication skills in English