Intern, Regional Quality Assurance the Americas in Bernards, NJ at DSI

Date Posted: 2/8/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.

Job Summary

Assist in Regional GMP Quality Assurance with audit proposals and tracking, preparing reports and presentations, applying Quality Audit metrics from the site data, preparing risk assessments and supporting Regional Quality Assurance meetings

Responsibilities

1. Quality Audit Metrics and Risk Assessment Project
2. Regional GMP Vendor Management (Audit standardization and tracking)
3. Rotate through DSI QA areas and be introduced to other departments
4. Ad Hoc Projects
5. GxP Quality Agreement Project
6. GxP Metrics (tracking and analysis)
7. GMP Supplier/Vendor Qualification

Qualifications

Education
  • Successful candidates will have a science background (pharmacy curriculum preferred) with a minimum of 3 years completion of College Science or Pharmacy.
Experience
  • Understanding of Pharmaceutical Industry, USP requirements, FDA Quality Requirements and Good Manufacturing Practices (GMP) as per FDA 21CFR 210 and 211, PIC/s and Part 11
Competencies
  • Good communication and time management. Ability to work independently and in team environment. Good attitude, willingness to learn and stretch, good planning, frequent communication with supervisor. Excellent computer skills required. Proficiency in MS Word, Excel and PowerPoint.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.