Quality Assurance Manager

バイオ医薬品企業でのQAマネージャーとして品質保証業務を担う

仕事内容

Quality Assurance System Lead’s position plays an important role in the GQP management performing a combination of both
administrative, tactical and strategic tasks. The position holder ensures compliance of GQP practices with regulation and
group requirements as well as supporting Tech-Ops organisation in supplying good quality product to the patients..
Job responsibilities will normally include all areas of GQP such as deviation handling, quality information management, change
control, traings, document management, and audits etc

The main responsibilities may include, but are not limited to
・Responsible for the day to day quality control of the Japanese operations.
・Develop and maintain a local quality system to support the release of a commercial product
・Development of local SOPs related to quality activities and review or approval of functional area procedures as required.
・To lead SOP traings
・Conduct internal process audits and external supplier audits as necessary.
・Ensure that the QA department collaborates closely with the Safety Management department and with other departments
concerned with quality assurance duties
・To supervise the QA duties
・To verify the QA duties are conducted properly and efficiently
・To report or to support reporting in writing whatever necessary for conducting the QA duties to the general marketing
manager, in addition to those items reported to him/her in cases where any deviation from the specified procedure has
occurred; reports of the results of the evaluation and verification of improvements by manufacturers, records relating to the
handling of information on quality and quality defects , records relating to the handling of recall of drugs and written reports
of the results of self-inspections
・Handlingor support handling an information on Quality etc and Quality Defects including examination and evaluation of
information, taking necessary corrective action, establishing records describing the details of the quality information and to
report or to support reporting in writing the records to the general marketing manager and providing information to the safety
management department with the quality information which is concerned with the measures to ensure safety
・Handling or support handling Recall -to segregate the drugs recalled and dispose of them properly after storing for a certain
period and to establish records describing the details of the recall and to report in writing to the general marketing manager.
・To communicate with or instruct in writing, where necessary, the manufacturers, etc., distributors, pharmacy proprietors,
hospital proprietors, clinic proprietors and other parties concerned, when conducting the QA duties.
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.

応募条件

【必須事項】

・5+ years experiences in GQP and/or GMP for medicinal products.
・Knowledge of Japanese regulation for GMP/GQP/GDP.
・Strong English communication
・Understanding 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
・Pharmacist

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 and data
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

【歓迎経験】

・Knowledge for basic GMP/GDP requirements of ICH/EU/US.
・Knowledge or experience for medical device GMP management.
・Experience with new product launches is a plus

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

3ヶ月

勤務地

在宅可、東京

転勤の有無

転勤なし

受動喫煙防止措置

敷地内禁煙（喫煙場所なし）

勤務時間

9：00～18：00

休憩時間

60分

時間外労働

有

勤務開始日

応相談

休日休暇

週休二日、国定休日、有給休暇

年収・給与

年収　　1000万円～1200万円　

諸手当

昇給

賞与

採用人数

1名　

待遇・福利厚生

【待遇】

各種社会保険完備

【福利厚生】

選考プロセス

１）書類選考
２）一次面接
３）二次面接
４）最終面接