QA Expert / Quality_Biopharma (Tokyo)

Job Number: 1169

External Description:

Department: GQP Compliance Group
Report to:　Head of Quality Japan

General

 

This role is to serve as an expert in the key quality management system for Japan subsidiary with regards to GxP requirements as well as Japanese Pharmaceutical Laws. 

 

Support Japan Quality Assurance Team and ensure the implementation and monitoring of the Quality Management System and their continuous improvement. 

 

Tasks will include the management of key Quality Management Systems such as document system, training, customer complaints, deviation, self-inspection, Change control, etc.

 

Another key area of this role is the maintenance of Foreign Manufacturing Accreditation (FMA) for the overseas manufacturing sites.

 

Key Responsibilities

 

Manage Quality Document System throughout the lifecycle of the quality documents (creation, revision, obsolescence) and ensure quality system is aligned with the HCQ standards and compliant with the local regulations; Creation and maintenance (periodic review) of Quality Standard Operating Procedures and Work Instructions and ensuring procedures are available via Mango; Maintenance of all appropriate documentation via document management system including electronic systems such as Mango.

Manage Training System to ensure the employees are capable and qualified for the operations according to the quality system; Maintenance of all appropriate documentation and recording of trainings via paper or electronic system (HR4You Learning)

Manage the Customer complaints including (but not limited to) the following activities: Maintenance of all appropriate documentation, recording and investigation of customer complaints via the complaint database Trackwise; return of complaint samples to manufacturing sites for investigation purposes and provision of information to complainants as required (complaint responses)

Manage Self inspections such as preparation of annual plan, execution of self-inspection, reporting of the results and monitoring of CAPA status.

Responsible for the compilation, tracking and sharing of trend reports, working with stakeholders to propose appropriate CAPAs.

Implement and monitor corrective actions to guarantee the coherence and efficiency of the individuated operative mechanisms.

Manage Foreign Manufacturing Accreditation (FMA) and GMP compliance inspection of manufacturing sites including new submission and maintenance of those licenses.

Assist with audit and inspection management / preparation carried out by the Health Authorities and corporate internal audits.

Assist with Risk Management activities

Actively participate in our Performance Management Process and Personal Development plan

Work within company Standard Operating Procedures, industry guidelines and apply our Values and Code of Conduct in daily duties and activities.

Perform other functions and duties that may be assigned by the Head of Quality.

To recognize a reportable adverse event (AE) and/or safety information which may be related to our products and ensure that the necessary information is forwarded to the Local Patient Safety Responsible Person (LPSR) within 24 hours.

Liaise with quality global functions (HCQ) and site quality to handle quality issues

Report regular QMS status and maintain a Quality Management System

 

1, Education

 

Bachelor’s Degree with a minimum of 3 years of experience in the pharmaceutical industry.

Background in Pharmacy, Life sciences, Pharmacology, Medicine or a related scientific discipline or other related field

 

2, Job Specific Competencies & Skills / Work Experience 

 

At least 3 years' experience related to Pharmaceutical or related industry, ideally with a mix of Manufacturing / QUALITY operations, Distribution Warehouse management or clinical development activities

Experience in Good Distribution Practices and Distribution Activity

Strong knowledge in local applicable laws and regulations

Willingness and enthusiasm to learn new skills Time management skills, ability to priorities and work in a busy work environment

Excellent communication skills Ability to work within a team environment and with cross functional teams

A demonstrated proactive, problem-solving mentality with strong analytical skills

 

ADDITIONAL REQUIREMENTS

 

Computer skills (Word, Excel, SharePoint, etc.)

Knowledge of software packages such as Trackwise, Documentation Management systems desired, Veeva, LEDOX, but not essential

 

3, Languages

 

Fluent in spoken and written Japanese, Upper middle level of English proficiency (fluent is written English)

Job Number: 1169

Community / Marketing Title: QA Expert / Quality_Biopharma (Tokyo)

Location_formattedLocationLong: Tokyo, Tokyo JP