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Senior QA Specialist

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

Job Requisition ID:  190685
Location:  Nantong
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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 HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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