QA Expert / Quality_Biopharma (Atsugi)

Posted 11 Mar 2024

Atsugi, Kanagawa - Japan

Req Id 272213

Work Your Magic with us! 


Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.


As a vibrant science and technology company, we believe in science as a force for good. We make a positive difference on millions of people´s lives every day.




Position: QA Expert

Location: Atsugi

Department: HC-GM-QCQAB QMS Compliance

Report to: Group Manager of QMS Compliance

Direct report: 0


Your Role

QA Expert is responsible to support for establishment and maintenance of overall Biopharma Japan Quality systems at Atsugi site, secondary packaging site of drug products.

The QA Expert is accountable for the quality and GMP compliance of:

Execute local quality control tests including check of packaging component and certificate of analysis according to product specifications and related working instructions.

Maintain product specifications to ensure compliance with approval matters.

Maintain local quality documents to assure documents are in line with global standard as well as local regulatory requirement.

Support training execution according to the annual plan and maintain the training matrix is up-to-date.

Manage site change control project to assure the change is implemented in a timely manner.

Execute self-inspection and supplier audit.

Execute investigation for quality issues such as complaints, deviation, etc. and implement CAPA in a timely manner.

Ensure reporting and escalation of identified risks.


Who you are


Bachelor above.

Background in pharmaceutical, chemical, physical, or related expertise.

Pharmacist license preferred but not essential.


Job Specific Competencies & Skills / Work Experience

Preferably >3 years' experience to handle quality related works under GMP/GQP/GDP/QMS for pharmaceutical, medical device, or related industry.

Experience in participating in PMDA/Prefectural inspection or/and self-inspection preferred but not essential.

Good negotiation skills with internal and external customers.

Good time and priority management skills.

Willingness and enthusiasm to learn and share knowledge.

Continuous improvement mindset, attention to detail, organizational skills.



Native level in Japanese.

Business (preferred), conversational (mandatory) in speaking, reading, and writing in English .


Additional Requirements

Basic computer skills (Word, Excel, PowerPoint etc.)



ポジション QAエキスパート

勤務地 厚木

部署 HC-GM-QCQAB QMSコンプライアンス

報告先 QMSコンプライアンスグループマネージャー



























Recruiting Contact: Maiko Yamasue


Register now to our new Talent Zone! It is a great way to stay connected, learn more about our company, career opportunities and events! Even you have no plan to apply a position now, please feel free to register to be visible to our internal recruiters and stay in touch for future opportunities.




Talent zone link:

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!


Apply now and become a part of our diverse team!

US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.

North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information:

Apply Now

Join our Talent Zone

You haven't found quite the right job yet? Join our Talent Zone and stay in touch with us. Be the first one to learn about our new career opportunities and events.

Tell us about yourself and let our Talent Advisors help you find your next career opportunity.