Quality associate

Job description

Purpose :

- Assuring that products are manafactured, imported or distributed appropriately according to quality ststem
- Managment of imported products including batch release and product complaints
- Risk managment including qualify alert and recall

Key Responsibilities:  

-Product maintenance including batch release, PTC management, deviation, change control, QC test.
-Support batch release

-Performing annual product review/ trend analysis

-Manage PTCs received by the affiliate according to defined Quality Standards & processes and in connection with Global Quality Functions and other relevant units

Manage product-related quality events (quality alerts/ recalls/ notifications to & from local Health Authorities) according to defined Quality Standards & processes and in connection with Global Quality Functions

-Provide Quality input within the affiliate in case of Product Alerts and/or Crisis Management

-Review and approval of package materials

-Support oversea GMP site inspection

Qualifications
-Background requirement: Health, life science or medical science degree (pharmacist preferred)
-Minimum 3~4 years of pharmaceutical industry experience (Quality and/or Regulatory affairs experience in multinational pharmaceutical company preferred)
-Excellent written & spoken English
-Functional Knowledge: Good knowledge of GMP( Good manufacturing practice),  GDP ( Good distribution practice) and Korea Good importation practice  
-Skills: Leardership, communication skill, time management skill, strong collaboration skill, sense of urgency, compliance mindset & computer skill

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.