Sr QA Specialist (Ref Id : 19189-RT)

Posted date: Aug-02-2010

Location: South San Francisco, CA)

Duties :
· Role will have accountability for managing all PQS project workstream activities for the gRED Clinical Operations organization.
· Duties will include strategic review of quality plan, and management of internal quality document development .
· Liase with gRED Clinical Science business management and communicate changes around deployment of new processess and documentation.
· Provide support for all functional roles to educate and inform for changes to GCP processes including strategic communication and delivery of formal announcments to Clinical Operations organization in support of the global initiative.
· Project management will include detailed project planning using MS project office tools. and documentation and/or GXP

Skills:
· Expertise for this role will include but is not limited to:
· Experience in SOP development and management in a matrix environment
· Understanding of the role of Quality Assurance in SOP systems
· Extensive clinical research knowledge, application of ICH/GCP and FDA regulations
QA professional with strong experience in GCP -Clinical Operations background preferred

Specific Skills:
· Candidates need to be interested in early development work
· Knowledge of the code of federal regulations, European Directives, ICH/GCP practices.
· Please concentrate on GCP-Good Clinical Practice /SOP development experience in the clinical trial arena

Education:
Minimum BS -Masters preferred. Seek seasoned QA professional with strong experience in GCP -ICH, controlled document development. Clinical Operations background preferred

Contact: Rakesh

The best telephone number to reach me is 973-481-0100 Ex:3104. I appreciate if you forward your updated word formatted resume at
/rakesh.tamadapamakroscientific.com for review before we speak.

For any reason, you are not able to submit your resume or for any further information, please call our Candidate Help Desk at 973-679-5005.or E-mail your resume at recruitermakrotech.com . We shall be happy to help you.

Job Title Sr QA Specialist (Ref Id : 19189-RT) Post Details
Email rakesh.tamadapamakroscientific.com Empolyer's Website makroscientific.com
Category Job Discipline Job Discipline -> Clinical Research Job Classification Job Classification -> Specialist Job Type Job Type -> Full-time Location South San Francisco, CA) Key Words strategic review of quality plan, and management of internal quality document development Start Date ASAP Salary Open Deadline