Job Description

Affilate Senior QA specialist /Affilate QA specialist

China, Shanghai, Shanghai

2 additional locations

ChinaChina, Shanghai

Quality Assurance

Requisition #1902769

1) Support activities related to product actions in the affiliate.

2) Assure key metrics are being met to ensure compliance and to drive continuous improvement.

3) Oversee coordination and investigation of key quality systems (ie. CAPA, product complaints) ensuring KPIs are being met.

4) Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.

5) Quality management of TPL including performance monitoring for key suppliers, QTA management and assessments.

6) Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

7) Participate in training and education programs for various aspects of quality assurance.

8) Quality management of TPL including performance monitoring for key suppliers, QTA management and assessments Organize the audit and risk assessment of TPL quality management system

9) Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.

10) Responsible for QA release/ QA hold in system,

11) Provide guidance and oversight procedure of drug purchase, storage, maintenance, sales, rejection, transportation, etc. to comply with GSP and Abbvie procedure; Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.

12) Confirm nonconforming drugs, and overseeing for the nonconforming drugs handling process;

13) Investigate, handle and report drug quality complaints and quality event / non-conformance ;

14) Provide guidance and oversight for setting the quality control functions of computer system;

15) Provide guidance and oversight for the user role design of computer system and the establishment and updating master data of quality management;

16) Organize the investigation and assessment on the quality management system and service performance of distributors and transportation vendor;

17) Organize the examination on the transportation conditions and quality guarantee capability of the carrier authorized for transportation

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, other scientific area.

• 3-4 years’ experience in quality assurance, operations, regulatory or relevant experience.

• Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations.

• Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products.

• Strong influencing, motivational, interpersonal and relationship building skills at all levels.

• Excellent written and oral communication skills. Proficiency in English.

• Negotiation skills, effective collaboration and ability to anticipate needs and requirements.

• Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache and Attache Pro.

Additional Information

  • Travel: No

  • Job Type: Experienced

  • Schedule: Full-time


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