Applicants must have permission to work in Japan
Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)
☑Foreign business ☑English language required ☑Japanese language required
Global Pharmaceutical Company
1. Implement and manage GQP-required quality assurance tasks (see below) including supporting tasks along with lead responsible in team and QMS tasks.
Documentation (Quality Product Codes, QTA GQP SOPs) *QTA : Quality Technical Agreement
Product GQP Release
GMP sites control including Change Management, Deviation/OOS Management, APR, GMP audit report and various validations reviews etc.
Quality Information including Customer complaints, product recall handling
GQP Self inspection, Corporate internal audit, Quality Review Board Activities
Training activities for GxP regulations
GQP audits/GxP audit
Others (Gap analysis between approval documents and actual MBR/BR in manufacturing process and analytical Spec and method, Quality Performance Indicator Monitoring, Quality Risk Register Activity etc.)
2. Establish, maintain and improve GQP quality system/company QMS fulfilled the requirements from applicable laws and corporate & local pharmaceutical standards.
GQP QM systems
EDM: Veeva Quality One Docs
Learning Management System: LMS
Quality Management System: TrackWise
Other applicable system: Artwork control system etc.
3. Implement stable supply of appropriate quality product to Japanese market via supervising and communicating with oversea and domestic manufacturing sites (for API, formulations, Packaging, external lab, important suppliers) and SNO/local SCM team *SNO: supply network organization at our global.
4. Regulatory Compliance Activities
Communications with health authorities for various topics
GMP Compliance inspection as to support Manufacturing sites as (domestic) representative as MAH
Foreign Manufacturing Accreditation maintenance/newly application (FMA)
MF maintenance (as to support CMC, RA team)
5. Ensure the realization of Goals and Objectives with priorities based on our strategy.
Provide the following opportunities via working experiences in this inspiring role.
From the view of organization size and existing products (approx. 20 SKU) and New product pipelines, given an opportunity to take a task in wider range of GQP activities to acquire comprehensive knowledge & skills for almost all elements of GQP activities.
Levelling up your English capability via frequent English communications in global organization.
Experiencing frequent cross functional activities via a QMS role to learn a lot about GxP world in the phases from R&D to post marketing.
Acquiring a wide field of view and a higher perspective with the frequent opportunities with direct communications with management.
Good working environment for "self-development" not required long working (we are strictly controlled as department) and relatively easily take a Paid Time/Day Off (as always recommending to take appropriate PT/DO) to keep personal time for learning or other personal leisure.
If you prefer to further deepen skills and experiences via work, it can be adjusted easily via priority.
Over 3 years' experience working in pharmaceutical industry and/or quality management such in Pharmaceutical Manufacturing Sites (QA, QC, Productions, Engineering/Validation and others) and HQs 's quality functions (GQP, SQM and others).
Familiar with GMP guidelines, regulatory requirements in pharmaceutical field.
Japanese proficiency: Fluent
English proficiency: Flexible.
Comfortable communicating in English. Fluency is not required.
Preferred skills and experience:
Business level English proficiency: Report and Collaboration with global members, attending a global conference, TOEIC: 730 or greater.
Bachelor's or above degree in pharmacy, chemistry, biology or related field.
Working experience in global, multinational environment.
8 million JPY - 15 million JPY (Experiences and skills will be considered)
Full 2 holiday week system (Sat/Sun), National holidays, New year's holiday, Annual Leave
Application screening and several interviews are scheduled.
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Quality Assurance, Analyst, Health Care Provider