(Janssen) Staff, Manufacturing and Supply Div., Fuji Plant, Quality Operations Dept., Quality Control Group, Quality Control Group

Johnson & Johnson Innovative Medicine (JJIM) is recruiting for a(n) Quality Control Senior analyst, located in Janssen Fuji Site, Japan.
This position is responsible for leading analytical method transfer for NPI to implement in country test.
The Quality control lab services group is responsible for implementation, improvement, and harmonization of laboratory quality systems in accordance with GMP and J&J quality guidelines. The team is also responsible for analytical change control, stability program management, review and implementation of compendia methods and quality standards, training, LIMS, Empower and other system administration, method improvement and analytical method transfer.
• Leads and supports analytical method transfer, method verifications for new products as local SME.

• Responsible for implementation, improvement, and harmonization of laboratory quality systems.
• Responsible for ensuring all laboratory systems comply with GMP and J&J guidelines and quality standards, including support to regulatory filings and acting as lead auditee and sub-system owner for laboratory systems.
• Encompassing activities in support of laboratory systems, e.g. compendia and quality standard review, stability program administration, analytical change control, LIMS, Empower, training, etc.
• Proactively supports GMP compliance, permanent inspection readiness, identification of compliance risks and breaches.

Education:
The candidate must have a strong scientific background with a chemistry, biology, biomedical or pharmacy degree, or a higher (MSc or PhD) degree is an asset. For candidates without a higher degree, at least 3-year experience in the pharmaceutical industry is required.
Experience and Skills:
Required:
Knowledgeable of global regulatory requirements applicable to biologics and/or pharmaceuticals
Understanding of PMDA/MHLW/JP or equivalent industry standards relevant for the QC laboratory.
Knowledge of different aspects of QC activities such as testing, equipment lifecycle management, data integrity, management of different systems in the lab and analytical method transfer.
Preferred:

• We are looking for candidates who value and act based on Our Credo Principles
• Excellent communication skills in both written and verbal with multicultural members
• Multicultural experience working with members from different backgrounds.

Other:

• English business level is required to communicate with global team.