高级质量保证专员

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:

PURPOSE OF THE ROLE

To maintain and develop distribution quality assurance system based on Healthcare Quality standards and with the local GDP (GSP) / GMP and regulatory, ensure that our company drug distribution activities comply with global requirements and local GDP/GSP regulations.

KEY TASKS & RESPONSIBILITIES

Functional Tasks

12. Responsible for daily supervision of 1132 distribution, guiding and supervising the quality management of drug storage, sales, returns and transportation, etc.
13. Responsible for the assessment and disposal of returned finished goods of 1132 distribution.
14. Responsible for evaluation of the shipping temperature data of temperature sensitive products and keep the products under appropriate status.
15. Responsible for the process of confirming nonconforming products and monitoring the process of handling nonconforming products.
16. Responsible for warehouse on-site quality monitoring.
17. Responsible for forwarder and logistic service provider management, communicate with them regularly, monitor KPI and set up follow-up action list to ensure continues improvement.
18. Responsible for CAPA management.
19. Provide support for shipping route validation from quality side.
20. Support distributors/forwarders/service providers audits.
21. Participates in quality management of commissioning warehouse.

MAIN INTERFACES

         Interfaces with other Departments/Functions: SNO, MSC, MNT QA

         External Interfaces: Good communication with LSP, forwarders and distributors; Local HA

Who you are:

EDUCATION/LANGUAGES

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

Licensed Pharmacist is preferred

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

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

PROFESSIONAL & TECHNICAL SKILLS专业技术能力

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

Professional knowledge in GDP(GSP)/GMP.

Problem solving ability and skills.

Ability to face challenge and self-learning.

Teamwork

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