GMP QA Associate

San Diego  ‐ Onsite
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Description

The successful candidate will assure cGMP compliance with applicable regulatory requirements including audits and documentation review. The candidate will also need minimum of 5 years experience within the GMP Pharmaceutical field.Primary Duties and Responsibilities
  • Represents and interfaces with Pharmaceutical Sciences and Regulatory Affairs to provide Good Manufacturing Practices guidance in an effective manner.
  • Reviews production batch records and associated data for product release; determines if records are within range of cGMP regulations.
  • Reviews Analytical Certificate of Analysis data packages for compliance with approved methods.
  • Archive and file QA documents.
  • Maintain vendor files and track and trend vendor deviation/out of specification and non-conformance events.
  • Develops, revises and reviews Standard Operating Procedures.
  • Reviews equipment calibration and qualification documents to ensure compliance with internal procedures and manufacturer performance specifications.
  • Trouble-shoots and takes the initiative on any QA-related issue for GMP compliance.
  • Reviews protocols, study reports, etc. for product release and method validation; ensures that no deviations from approved protocols were made without proper authorization/documentation were performed in accordance with the GMP guidelines.
  • Carry out job responsibilities and assignments safely and maintain a clean and safe work area.


  • Bachelor's (BS) or higher in the Life Sciences or related discipline.


To find out more about Real please visit www.realstaffing.com
Start date
07/2013
Duration
1 Year
From
Real Staffing
Published at
18.07.2013
Project ID:
569071
Contract type
Freelance
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