Expires soon Johnson And Johnson

【Janssen】Business Quality Product Quality Complaints Sr Specialist

  • Tokyo (Shinjuku-ku)
  • Design / Civil engineering / Industrial engineering

Job description

Job Description

Requisition ID: 1805704702W

Overall purpose of job:

This role aims to ensure key compliance requirements for GQP ordinance in Japan and J&J global standards for Business Quality (BQ). The role will play a key role in management of product quality complaints as per MHLW expectations as Marketing Authorization Holder, and J&J global standards.

Essential duties and responsibilities:

Responsibilities include, but not limited to:

·  Manage product quality complaints from customers in compliance with the procedures and relevant regulations, and report (escalate) the information to the Quality Assurance Manager appropriately.
·  Manage product quality complaints intake process and Trackwise records until completion.
·  Lead development of communication with the customers.
·  Work with Medical Representatives in appropriate communication with customers.
·  Review acceptability of complaints investigation reports to closure.
·  Work with Pharmacovigilance on combined adverse event/product quality complaints from customers in compliance with procedures and relevant regulations
·  Prepare trend analysis reports of product quality complaints and initiate relevant actions.
·  Ensure local execution align with Japanese regulations and J&J global standards
·  Contribute to the BQ mission, vision and strategy
·  Contribute to Quality deliverables for Japan
·  Support GxP systems (CAPA, Change Control, Deviation, Training etc.)
·  Contribute the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements.

Desired profile

Qualifications

Special requirements:

·  +2 years of directly related experience in quality assurance and quality related activities.
·  Demonstrated ability to manage relationship development and maintenance, and negotiation skills.
·  Product lifecycle management experience (preferable: pharma)

Other features of the job:

N/A

Job location:

J&J Tokyo Head Office, Japan or
J&J Fuji Plant, Japan

Job Requirements

Essential knowledge and skills:

·  Experience with Japanese pharmaceutical companies
·  Good communication skills both in English and Japanese
·  Good verbal and written communications skills. Must be able to articulate ideas with same levels of an organization.
·  Knowledge in basic pharmaceutical laws and GxPs such as GMP, GQP, GDP, GLP, GCP etc
·  Project management skill


Core competencies required for this role:

·  Leadership as an individual contributor to challenge the status quo and how things have always been done.
·  Motivation with high personal integrity and application of J&J Credo Values in daily operations.
·  Leadership experience leading projects, programs or other global initiatives
·  Can show his/her agility, ability to learn fast and comfort in complex environment.
·  Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with key stakeholders

Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Quality Assurance
Requisition ID
1805704702W

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