Senior QA Technical Specialist

Position 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.

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).
• Meet internal training requirements (per assigned training curricula) and keep oneself up to date on current GMP and other relevant regulatory requirements as well as relevant guidelines for computerized systems
• This position has interactions to Engineering as well as all other QA functions locally and globally.

Education and Experience Requirements:

• High School Diploma or Equivalent with
  12years of applicable industry experience
  OR
• Bachelor’s degree with8years of applicableindustryexperience
  OR
• Master’s degree6years ofapplicableindustryexperience
  OR
• Ph Dwith4yearsofapplicableindustryexperience
• Solid GMP knowledge

Preferred Experience:

• QA and/or manufacturing experience from the pharmaceutical industry

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.

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 ().