南京招聘

职位描述：
岗位职责:

POSITION:
Senior QA Engineer - Commercial Affiliates Quality Assurance – China

The main functional task is
SOP system establishment and maintain.
Risk assessment and audit for distributors.
Distributor qualification, technical and quality agreement management.
Manage routine quality activities related to distributors.

Job Description: Quality management and oversight processes within China & Hongkong under his/her responsibility will include but are not limited to:

? Ensure implementation of and on-going compliance with applicable regulatory requirements for all GxP areas i.e. GMP, GDP, PIC/S and the Bracco Code of Ethic, Policies, and Quality Guidelines as well as with Industry Best Practices.

? Design, implement and maintenance a Quality Management System to assure pharmaceutical products and medical devices quality in commercial affiliate and supply chain.

? Drive together with the Commercial Affiliates Quality Units and the Commercial Affiliates Head the creation and implementation of quality culture across countries in the region.

? Drive the implementation of the Regional Quality Organization on local level. Ensure implementation of applicable Quality Standards and governance processes.

? Establish annual audit plan for distributor based on risk assessment and business need. Conduct on-site audit and ensure CAPA being managed effectively.

? Compliance and qualification management of distributors. Participate new distributor development, e.g. due diligence visit. Sign and maintain Quality and Technical Agreements with all GSP related distributors.

? Ensure implementation of defined Key Compliance / Quality Indicators KC/QI in the region to monitor on an on-going basis that relevant processes are in control and compliant as well as that regulatory controls are in place in relevant process steps.

? Regularly review and assess KC/QIs of the concerned region. Ensure that potential compliance gaps and risks are addressed and opportunities for continuous improvement identified and the annual Regional Quality Plan implemented in the countries.

? Provide quality oversight for deviations and ensure that root causes are identified and adequate CAPA’s are implemented.

? Provide quality oversight for change control, complaint handling, product recall, etc.

? Liaise effectively across e.g. TechOps Supply-Chain, Regulatory Affairs and Procurement to ensure that global processes are adequately implemented and projects are successfully launched in the countries.

? In liaison with the local GM&RA to ensure effective communication with local Health Authorities is adequately shared within the organization and commitments tracked and closed on time. Inform CQM about all the requests or regulatory alert fields by the local regulatory agencies;

? Support, assist with Local Affiliates for the preparation of Health Authorities Inspection and Third Party audits

任职资格:

Desired Skills & Experience:

The MUST requirement is to have
At least 5 years experiences in MNC in pharmaceutical or medical device.
GMP & GSP audit experience.
Experience in CAPA, deviation, complaint handling, change control.
SOP draft and revision.

1. Degree in Life Sciences, Chemistry, Pharmacy or related fields.

2. A minimum of five years of Quality Assurance experience and involvement in pharmaceutical or medical device industry; broad understanding of GMP, GDP, PIC/S, ISO 13485 and Pharmacovigilance.

3. A minimum of three years of demonstrated QA experience in commercial affiliates and supply chain in a global/matrix environment in the pharmaceutical industry

4. Knowledge and experience of GMP/GSP audit, validation, CAPA, risk assessment, data analysis is highly preferred.

5. Strong management, interpersonal, communication, negotiation and problem solving as well as project management skills

6. Considerable organization awareness e.g. interrelationship of departments, business priorities, including significant experience working cross-functionally and in global teams.

7. Demonstrated experience of successfully leading an organization or project.

8. Good English in reading and writing.

9. Practical experience in SAP, ERP.

10. Ability to travelling and good cooperation in team.

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Shanghai Bracco Sine Pharmaceutical Corp. Ltd.
博莱科集团是在世界影像诊断领域享有极高声誉的著名公司之一，其在国际市场上非离子造影剂的市场份额达世界排名前列，集团总部设在意大利的米兰，业务遍及美国、荷兰、瑞士、日本、新加坡、中国等一百多个国家和地区。2001年12月与上海著名制药企业信谊药厂合作组建了上海博莱科信谊药业有限责任公司，注册地在浦东金桥出口加工区。公司生产小容量和大容量注射液，主要产品有X射线造影剂，核磁共振（MRI）造影剂和超声造影剂。产品销售到中国大陆、中国香港和中国澳门地区。
为合作公司业务发展需要，现招聘符合要求的有志之士加盟上海博莱科信谊药业有限责任公司。请应聘者在个人简历上注明应聘职位、期望工资、身份证号码、白天可联络的电话号码。
想了解公司更多信息请登陆公司网址：http://www.braccosine.com

请注意：凡通过公司面试并最终决定录用的意向候选人都必须通过专业的背景调查，合格的候选人才能录用为正式员工。