POSITIONS

 
Japan
TBG-018314

Company:

Life Sciences

Position:

8-02 External Quality Assurance QA/QA スペシャリスト

Salary(¥):

6-11 million

Responsibilities

1. Quality Assurance Business Relationship with Outside Partners, including Outsourcing Partner
2. Perform quality assurance activities for external partners (mainly in Japan) based on domestic and overseas regulatory requirements and Merck's policies and guidelines.
3. Collaborate with the business and technical departments to support product supply and launch of new products (preparation for correspondence inspection of authorities).
4. Conclusion of agreement on quality with external partner and maintenance thereof. Support creation of contract entrustment contract with outside partner.
5. Implementation of DD (Due Diligence) for new external partners. In addition, we will provide support to improve the deficiencies found in DD and Pre Contract Audit.
6. Collaborate with external partners to build an effective and robust quality system. If necessary, provide necessary guidance on the preparation of quality procedure documents.
7. Develop quality monitoring programs for external partners according to product type, capacity and performance.
8. Adopt internal and external adjustments for the introduction of new products at external partners. We will provide appropriate support from the viewpoint of quality and appropriately transfer analysis methods and manufacturing methods.
9. It will be the regulatory authority response window on quality as necessary.
10. Quality Assurance activities for external partners including toll manufacturers.
11. Assures that external partners in Japan operation within established policies / procedures.

Requirements

1. It is desirable to have a degree in biology, microbiology, pharmacy, chemistry, chemical engineering, or equivalent. Deep knowledge and extensive experience on quality assurance, quality control.
2. Excellent communication skills in Japanese / English.
3. Networking skills, skills to build appropriate relationships with stakeholders.
4. Be familiar with domestic and foreign regulatory regulations, official documents etc
5. Knowledge of some degree of finance.
6. Interpersonal skills and powerful leadership skills to handle non routine, business in diverse cultures.
7. Must have strong demonstrated communication skills in Japanese and English. Must have demonstrated personal networking and Relationship building skills.
8. Must be conversant with all applicable regulations and compendia governing operations. Some level of contractual and financial awareness is required.