Large US-based Pharma company
・The key role of the SCQ (Supply Chain Quality Specialist )S is to establish and maintain an appropriate and sustainable Quality Management System and Quality Culture within our country office in order to ensure compliance with company and Regulatory Authority expectations.
・SCQ S is the Quality Responsible Person related to distribution activities, focusing on the management of authorized activities and the accuracy and quality of records.
・SCQ S is the main point of contact for the investigation and resolution of all product quality issues detected or originating in our country office and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, Business Units) and our Global Supply on such issues.
・SCQ S monitors the product quality and compliance activities within our country office to ensure current regulatory expectations are met, and facilitate internal and regulatory GMP/GQP/GDP inspections.
・SCM S will be able to get supports from Manager to achieve the purpose above.
1. Resolution of Product Quality and Compliance Issues
1.1. Deviation Management (in conjunction with Global Supply Quality Operations):
Investigates, together with appropriate local functions, deviations from Product Quality and Compliance requirements that occur within the responsibility of our country office and agrees and tracks preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeits, temperature excursions during transport or issues with contract manufacturers or logistics service providers etc.
1.2. Customer Complaints handling:
1.2.1. Ensures that relevant customer complaints are dealt with effectively.
2. Quality Management System
2.1. Ensures timely implementation of all applicable Product Quality SOPs (issued by SCQ).
2.2. Ensures that initial and continuous training programs are implemented and maintained for all relevant colleagues.
3. Local Product Disposition
3.1. Responsible for the local release of products under the distribution license, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.
4. Inspections and Internal Audit
4.1 Supports the Responsible Person (RP) in the preparation and coordination of GMP/GQP/GDP Regulatory Agency inspections.
5. Subcontracted activities with GMP/GQP/GDP impact
5.1. Approves any subcontracted activities which may have an impact on GMP/GQP/GDP: Develops, negotiates and maintains up to date Quality Agreements with GMP/GQP/GDP contractors, e.g. Logistics Service Providers (LSPs), relabeling/repackaging contractors.
6. Quarantine Alert Notices
6.1. Receives and manages Quarantine Alert Notices received from Primary Logistic locations.
6.2. Establishes if product lots remains at LSP and, if so, alerts the LSP to place the product on hold.
7. Oversight of local Relabeling and Repackaging Operations
7.1. Ensures relabeling/repackaging contractor has been internally assessed and approved.
8. Development and Maintenance of Consistent Quality Culture
8.1. Collects data and metrics on the quality performance and communicates this to the Management of SCQ. This involves a regular Management Quality Review process.
9. Suppliers' and Customers' Qualification
9.1. Ensures that suppliers and customers are qualified in accordance with GMP/GDP-requirements. Provides local support, upon request, to the RP, for the customers' qualification.
10. Pharmacovigilance and the compliance to rules and ethics codes
10.1. Completes in due time the "Your Reporting Responsibilities: Monitoring the Safety, Performance, and Quality of our Products" training program and the annual re-training.
11. Personal development through
11.1. Active participation in our trainings, assignments, projects.
- Has an appropriate education in science or quality topics.
- Has appropriate technical and quality experience to management expectations.
- Makes sound and effective quality decisions under pressure.
- Computer literate
- Fluent Japanese and English communication skills - verbal and written
- Strong negotiation and effective communication skills.
- Self-motivated individual who is comfortable with working independently
- Awareness of cross-cultural differences
- Able to lead and work effectively in cross-functional teams
Several years of relevant experience in the pharmaceutical industry
Full 2 holiday week system (Sat/Sun) national holidays
New year's holiday
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.