Senior QA Technical Specialist

Overview

The Senior QA Technical Specialist acts independently and provides QA subject matter knowledge in the GMP domain to systems and projects with focus on key quality activities and deliverables in accordance with company policies/SOPs and regulatory requirements. Works closely with project teams and stakeholders across the organization, support development and maintenance of computerized system and data integrity PQS subsystems.

External US Major Accountabilities

• Review and approval of validation documentation against PQS subsystems Computerized Systems and Data Integrity processes and requirements.
• Review and approval of qualification documentation against PQS subsystems Computerized Systems and Data Integrity processes and requirements.
• Review and approval of changes, events/deviations, incidents, CAPAs etc. (process records) as well as procedural documents in relation to computerized systems.
• General inspection and audit support in relation to computerized systems.
• Develop and maintain the PQS framework related to computerized systems and based on current GMP and other relevant regulatory requirements (per global policies).

Education And Experience Requirements

• High School Diploma or Equivalent with 12 years of applicable industry experience OR
• Bachelor’s degree with 8 years of applicable industry experience OR
• Master’s degree 6 years of applicable industry experience OR
• PhD with 4 years of applicable industry experience

Solid GMP knowledge

PREFERRED EXPERIENCE:

• QA and/or manufacturing expeirence from the pharmaceutical industry

Education

• High School Diploma or Equivalent
• Bachelor’s degree
• Master’s degree
• PhD

Experience

• 12 years of applicable industry experience
• 8 years of applicable industry experience
• 6 years of applicable industry experience
• 4 years of applicable industry experience

Skills

• Strong GMP knowledge

Benefits

Not specified

Pay

Not specified

Schedule

Not specified

Contact

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com).