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质量保证副经理

A career at Merck is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 352 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your role:

Overall job purpose

Assist supervisor to build up and maintain sustainable quality system based on global standards and local GSP requirements.

 

Responsibilities

Urge the personnel of relevant departments and posts to execute the laws and regulations for drug management and GSP Practice.

Maintain sustainable quality system of NTGSP, guide and supervise the implementation, to ensure Nantong logistics center complies with local GSP requirements and global quality standards.

Responsible for local quality document system management, including following contents:

Responsible for document lifecycle management and the specific operation of format reviewmaking effectivedistributewithdraw and obsolete;

Maintain local document list.

Inform and follow up the related department to perform SOP periodic review.

Archive all paper documents of document lifecycle.

Undertake related responsibilities as Mango SLU.

Responsible for Personnel and Training management

Personnel Management: maintain and manage JD, signature and personnel roster, personnel individual file.

Training Management: establish training matrix and training plan, organize and coordinate the completion of related trainings and training summary.

Coordinate the quality objective setting and periodic review for every department.

Collect and analyze quality information, monitor the implementation of related laws and regulation in concerned departments and positions.

Support quality technical agreement management of enders and suppliers.

Participate in global and local document evaluation.

Distributor qualification and audit support.

Participate in self-inspection and internal audit.

Back up for QO colleague, such as incoming inspection and product release, etc.

Keep well relationship with stakeholders.

 

Who you are:

Skills, Performances & Competences required by the position:

  • EDUCATION/LANGUAGES

Bachelor degree or above in pharmacy, biology, chemistry, medicine or other related area.

Licensed Pharmacist. (mandatory)

Good English skill at reading, writing, listening and speaking.

Above 3 years quality experience in GMP or GDP (GSP) area.

 

  • PROFESSIONAL & TECHNICAL SKILLS

Good communication skills of both scientific and non-scientific information.

Professional knowledge in local regulations.

Problem solving ability and skills.

Ability to face challenge and self-learning.

 

HR: 95777

Functional Area: Quality

 

What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2merck.com

 

职位需求编号:  242643
位置:  Nantong
职业阶段:  D - Professional (4-9 years)
工作时间模型:  full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


职位细分: Inspector, Pharmacy, Quality, Healthcare

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