Quality Assurance Associate

Position Purpose

Quality Assurance Associate – Japan

• CSLB社の基準や本邦の規制に沿って適切に遂行する

To operate appropriately routine quality events (market release, deviation, complaint and change) in compliance with internal / global CSLB policies and local regulatory requirements

To collaborate with internal partners, such as sales department, marketing department, medical affairs, regulatory affairs and manufacturing sites

To appropriately communicate with the local external customers and parties, such as hospital, patients, wholesaler, physicians, J-3PL and laboratories

To establish new simple and clear operational practices in accordance with the global policy and local regulatory requirements

Responsibilities

To conduct SLP (Summary Lot Protocol) preparation and batch release activities. Negotiate with NIID on lot release queries and feedback

CSLB社の基準や本邦の規制に沿って適切に遂行する

To Operate routine QA activities mainly customer supports, such as complaint handling and query respond in compliance with internal / global policies and local regulatory requirements

To Collaborate with internal partners

Manufacturing sites : to manage changes, to request investigation for deviations / complaints and create customer communication letter

Regulatory Affairs : to manage changes, to check whether or not there’s no discrepancy between the registered dossiers and the actual operation

Sales and Marketing : to support stable commercial operations, especially complaint handling

Medical and Regulatory Affairs : to mutually prepare query respond

To Communicate with external customers and parties (hospital, wholesaler, physician, 3PL, external laboratories)

CSLBの基準や本邦の規制要件に沿った簡素で標準化された新しい手順の確立

To Establish new simple and clear operational practice in accordance with the global policy

To Oversee projects, if necessary

Position Qualifications and Experience Requirements

Bachelor degree or equivalent degree holder

Intermediate or Advanced level in English (reading and writing, conversation)

More than 3 years Experiences in working at Pharmaceutical industries and / or GxP (preferable; GMP and GQP) fields.

Background and knowledge in Plasma manufacturing and Quality Control testing

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.