Quality Assurance Specialist

3 days ago

Shanghai, Shanghai, China half the sky Full time

About Us:

Organon is a global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Womens Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.

A Day in the Life:

We are seeking a Quality Assurance Specialist to join our team. As a key member of our quality management systems implementation and maintenance team, you will be responsible for ensuring that our processes meet company QMS and local regulation requirements. This includes maintaining and updating Drug Distribution License and MD Distribution License applications, as well as providing critical support to ensure related processes meet GSP requirements.

Your Key Responsibilities:

  • Support China quality lead for quality management systems implementation and maintenance
  • Maintain and update Drug Distribution License and MD Distribution License applications
  • Provide critical support to ensure related processes meet GSP requirements
  • Conduct internal audits and investigations on audit findings, developing CAPAs for quality management system continuous improvement
  • Manage GSP/GDP Training system to ensure training and qualification of employees
  • Be the key person on 3PL distribution quality lifecycle management contact to ensure product quality during storage, maintenance and transportations etc.
  • Lead Drug Annual reporting process and work with RA, PV and SCM etc., to ensure timely submission
  • Responsible for product local release activities to ensure timely delivery of products
  • Perform other related duties as assigned by management

Your Skills and Qualifications:

  • Bachelor degree in pharmaceutical or related field
  • China Licensed Pharmacist
  • At least 5 years of experience in quality, compliance or relevant field in pharmaceutical industry
  • Prior experience in MNC pharmaceutical Drug Distribution company preferred
  • Effective English skills for communication in verbal and writing
  • Effective communication skills

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