Saitama Quality Expert

job title:   SAITAMA QUALITY EXPERT (Quality Assurance)

 

1. Quality Assurance:
We seamlessly supply high quality products to the Japanese market.
Develop and maintain the latest quality system at Saitama site and ensure that the quality system is in perfect compliance with the latest local HA requirements, pharmaceutical industry guidelines and UCB quality policies and standards.
Achieve relevant KPI goals.

2. Support and training Support employees to achieve their goals, teams and individuals.
Improve your associate's knowledge and skills.

3. Continuous improvement:
Engage in OE (Operational Excellence) activities to improve the quality and productivity of the Saitama site.

4. Work on HSE:
HSE activities to ensure the health and safety of yourself and your peers.
Minimize the impact on the environment.　　　　

 

Lead the following quality-related matters, depending on the product and / or area assigned . Review QA release batch records for APIs, Excipients, Packaging Materials, Consumables, Bulk And Products Investigate Anomalies, Deviations And Claims With The Investigator. Owners And CAPA Plan Of Creation And QA Of The Validity Check Of Newly Issued Or Revised SOP And Reviewers Of The Recording Format Over Protocol And The report of the review.

APQR 

Achieve the KPI target communication activities
Continuous improvement of quality and the quality system of products
Continuation of individual workflow and procedure improvement
Lead and participation of HSE activities carried out in the QA department
 
(the pharmaceutical industry) experience 5 years or more is desirable

  (English) Beginner (those who are learning is good)