Pfizer Asia Pacific Pte Ltd

质量体系与合规工程师 (BB-0B522)

Found in: Neuvoo CN

Description:

Job Description :

为了确保产品质量以及工厂的运作符合cGMP和辉瑞质量政策的要求,在质量体系与合规经理的指导下,有效执行质量合规相关工作,维护相关质量合规管理系统。
To execute quality compliance relevant activities and maintain site Quality Compliance Management systems under guidance from Quality System & Compliance Manager, with objective of ensuring product quality and the site operations are executed in light of cGMP, Pfizer Quality Standard (PQS) and site procedures.
主要职责 Role Responsibilities
  • 根据辉瑞总部的质量目标制定,监督和执行工厂质量与合规方面的战略目标。
    Develop, oversee and execute site Quality compliance objective as per Pfizer global quality objective.
  • 管理和维护工厂内审体系,确保工厂操作符合cGMP和PQS的要求,致力于持续改进工厂的质量合规水平。包括但不限于: 制定工厂内部审计年度计划,参与和协调工厂内审,内审体系定期回顾和趋势分析,工厂内审员的发展等。
    Manage site internal audit program, to ensure site practice compliant to cGMP and PQS requirement, and work on continues improvement of site compliance. It includes but not limited to: Develop site internal audit annual plan, coordinate and participate site internal audit, perform periodic review and trend analysis for this program, develop site GMP auditors.
  • 推动检查就绪体系的实施,协助外部审计和检查的接待。包括但不限于制定并维护工厂检查就绪方案,维护子系统所有人及区域专家名单,跟进检查就绪方案的落实,完成体系定期回顾。
    Drive site Inspection readiness plan and assist external audit/inspection hosting. It includes but not limited to: Establish and maintain SIRP (Site Inspection Readiness plan), maintain a name list of site SSO and SME; coordinate the implementation of inspection readiness plan, complete periodic review of site Inspection Readiness Plan etc.
  • 支持供应商审计,为工厂管理的供应商制定审计计划并负责实施。
    Support supplier audit. Responsible for developing and execute audit plan for site managed suppliers.
  • 作为总部合规组织(如PQS小组/药典事务小组/注册部)的工厂联络人,关注药品相关法规和PQS的动向,管理工厂差距分析及意见反馈,确保工厂保持与法规的一致性。
    As site contact of Pfizer Global compliance functions (such as PQS team/CAG/Regulatory Affairs), pay close attention to regulatory and PQS, manage gap analysis and comments feedback at site level, ensure site practice compliant with regulation requirements.
  • 提供相关的GMP培训,提高员工的质量意识和GMP知识。
    Deliver GMP training as required, to improve the employee's GMP awareness and knowledge.
  • 负责本地备案工作以及联络监管机构等业务,支持注册部资料准备工作如临床试验申报,产品注册等。
    Responsible for local filing business and communication with local regulations, and support document collection for CTA and/or NDA.
  • 执行公司安排的其他相关工作;

Execute any other related work assigned by company;
任职资格 Qualification (最低任职要求 Minimum Requirements)
  • 教育程度/经验 Education/Experiences
  • 具有药学,化学或生物相关专业本科学历;具有5年或以上的制药企业质量相关工作经历(至少3年及以上的生物制药或无菌生产设备,工艺验证),熟悉掌握GMP知识及其应用;
    Pharmaceutical, Chemical or Biological related Bachelor Degree; No less than 5 years of working experience in Pharmaceutical Quality (at least 3 years of working experience in equipment qualification or process validation of Biologics or Sterile/Aseptic manufacturing) , and proficient in GMP related knowledges;
  • 特别知识/技能 Specific Knowledge & Skills
  • 生物制药和无菌生产和质量管理相关知识;
    Biologics and Sterile/Aseptic manufacturing and quality management related knowledge;
  • 熟悉质量风险管理,掌握相应工具的运用;
    Familiar with Quality Risk Management, and also the application of relevant tools.
  • 具备产品工艺及设备验证经验;
    Experienced on product process validation and equipment qualification.
  • 熟练的英语听说读写能力和计算机office软件应用能力;熟悉GMP管理体系的建立;有效的系统思考能力和沟通技能;有效的组织协调能力和团队协作能力;有效的执行力和达成结果的能力;熟悉掌握分析问题、解决问题以及质量风险管理的理论及其工具。

Proficient in using English as working language at listening, speaking, writing and Proficient in Office application; Fully capable of establishing GMP Quality Management System; Effective Systematical Thinking and Communication ability; Good Coordination and Collaboration; Effective execution and result driving; Good at Problem solving and Quality Risk Management knowledge and Tool application;
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control

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