Senior QA Specialist

Posted 11 Apr 2019

Nantong, Jiangsu - China

Req Id 190685

Details

 

A career 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 performance materials. For more than 350 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:

The QA Specialist role will entail ensuring compliance with all regulatory and corporate requirements in support of regulatory (ISO, Chinese GMP, EU GMP and applicable agencies) and customer expectations, by carrying out routine quality assurance and quality control tasks and activities.

This position will ensure that efficacious and safe products are released to the market for sales. It covers the scope of Production Quality, Documentation System, Deviation Investigation and Quality Management System continuous improvement, to ensure the systems compliance with all Domestic and Global regulatory and corporate requirements.

The Main Tasks will be as below:

  • To coordinate and ensure timely releasing of incoming materials.
  • Responsible for shop floor inspection and control for the whole production process to ensure the whole production process control can meet with site procedures
  • Product Release: Review quality control documents, e.g. batch manufacturing records, packaging records and associated documentation in support of batch disposition. Make decisions to release or reject in–process material and final products.
  • Deviation investigation: To overall organize and coordinate site deviations investigating and handling.
  • Participate the management of routine quality affairs: including the handling of change control, customer complaints and investigation of other quality issues.
  • Work with QA team to perform continuous improvement to ensure site can meet all Customer & quality requirements.
  • Support for quality related tasks of transferring products from different giving sites to Life Science Nantong.
  • Complete other QA related work assigned by QA manager.
  • Be a valuable team member of Quality organization through close teamwork and cross functional/sectional activities.

 

Who you are:

  • Education:
    • BS in Pharmaceutical/ Chemistry or equivalent.

 

  • Working Experience:
    • Minimum 5 years of working experience in an international pharmaceutical or biological GMP/ISO environment with GMP/ISO experience. Aseptic experience is preferred.
    • Good experience in product release.
    • Good experience in deviations investigation and root cause analysis.
    • Experience of E-Quality System like Trackwise, FirstDoc or SAP system is preferred
    • Experience of customer audit is preferred.
       
  • Technical & Professional Knowledge:
    • Fluent in English. Good reading, writing and communication skills
    • Can work under pressure, handle and overall manage multiple tasks.
    • Result orientation, accuracy and reliability as a must
    • Excellent communication, problem-solving, planning and organization skills

Functional Area: Quality


What we offer: 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 https://jobs.vibrantm.com
 

Apply Now

Let’s stay connected

Do you want to receive company news and information about career opportunities tailored to your preferences? Sign up here. You want to check the status of your application or change your candidate profile? Enter our job portal.

Redirect

You have accessed https://www.emdgroup.com, but for users from your part of the world, we originally designed the following web presence https://www.merckgroup.com.

Let's go

Share Disclaimer

By sharing this content, you are consenting to share your data to this social media provider. More information are available in our Privacy Statement