Senior Specialist Of Quality Systems

I am currently in charge of finding the new Sr. Specialist of Quality Systems for a mid-sized pharmaceutical company in the San Jose area. This company currently has over 20 on-going clinical trials and will be going commercial with their oncology drug by 2014. I have spoke 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.
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Working knowledge of developing and establishing quality indicators and metrics.
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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.
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