【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