Overview
Quality Assurance Manager Jobs in Tokyo, Tokyo, Japan at Sobi – Swedish Orphan Biovitrum AB (publ)
Title: Quality Assurance Manager
Company: Sobi – Swedish Orphan Biovitrum AB (publ)
Location: Tokyo, Tokyo, Japan
Company Description
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
Job Description
Manager of Quality Assurance conducts the works in accordance with regulations (Drug and Medical Devices act, GQP ordinance etc.) and Global role of quality management system based on experiences of Quality (Pharmaceutical QA, QC, Manufacturing etc).
The main responsibilities may include, but are not limited to
creation and maintenance for Quality Standard code.
management for Quality agreement between manufactures etc.
review of documents and records for marketing release.
audit to manufactuers, suppliers etc. (GQP,GMP, GDP etc) for local and oversea sites.
change control and deviation control
handling for complaints and non-conformance
creation and maintenance of SOPs (Local regulation and Global requirements)
Self-inspection
management of Training
document and record control
other quality control related jobs
communication between global Quality teams and external suppliers for quality matters.
Integrating CARE
Collaborative: Creating and maintaining a motivating environment for all team members.
Cross-functional communication: Being able to collaborate and handle tasks in complex reporting lines (local and regional).
Accountable: Updating upper management on a regular basis and keeping a regular and reliable communication flow.
Respectful: Trusting and reliable sparring partner for both management and colleagues
Engaged: within Sobi community, sharing best practices, implementing new Sobi policies, following up on SobiCareer activities.
Qualifications
Education/Learning Experience/Work Experience
Required:
3+ years experiences in Quality (GMP and/or GQP) for pharmaceutical products.
Knowledge of Japanese law and regulations such as Drug and Medical Devices act, GQP, GMP and GDP.
Strong English communication
Experience of manufacturing control and quality control.
Customer focus mind-set and provide effective solutions to others.
Good verbal and written communication skills (both Japanese and English)
Good business and reporting skills
Communication and Team work skills
Desired:
Pharmacist
Experience of QA Manager
Skills/Knowledge/Languages
Required:
Japanese as mother tongue, and Fluent in English, verbal and written, at the level of TOEIC score higher than 730 .
Computer literate, with good working knowledge of Microsoft Office and the ability to learn Sobi system as required
Understanding of handling confidential information
Personal Attributes
Required:
Service minded with a high drive and accountability
Good team player and network builder, but also capable of managing tasks independently
Good communication and interpersonal skills
A “doer” with a delivery mind-set, flexible, ready and able to exercise initiative
Ability to multi-task and to operate efficiently in a fast moving environment also when under pressure
Ability to prioritise among tasks with tight deadlines
A willingness to learn
Good attention to detail
Maintain a professional approach, with a high degree of integrity in all interactions, externally as well as internally
Additional Information
This role will be office based with the possibility to work from home in agreement with the line manager. Candidates need to be flexible to travel to business meetings and support Sobi activities at international and regional meetings.
