Sr. Specialist Of QA Systems

San Jose  ‐ Onsite
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Description

I am currently in charge of finding the new Sr. Specialist of Quality Systems for a mid-sized pharmaceutical company in theSan Josearea. This company currently has over 20 on-going clinical trials and will be going commercial with their oncology drug by 2014. I have spoken directly with the hiring manager and I know that the most important thing for a candidate to posses is passion because they are racing against time to save lives. The best candidates should also have experience with the following.
  • Excellent working knowledge and understanding of GMP-related requirements, proficiency of regulatory and ICH guidelines with the ability to assess risk.
  • Excellent working knowledge of Quality Systems and cGMP standards applicable to clinical trial materials.
  • Working knowledge of developing and establishing quality indicators and metrics.
  • Detail oriented with Quality Assurance background with solid problem solving acumen. Ability to work effectively in a team environment with great organization skills.
  • Lead root cause analysis and develop associated CAPA to prevent recurrence and ensure completion of effectiveness checks.


Responsible for continuous improvement of core quality systems to ensure optimization without compromising regulatory compliance

To find out more about Real please visit www.realstaffing.com
Start date
11/2013
From
Real Staffing
Published at
11.11.2013
Project ID:
625423
Contract type
Permanent
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