Wednesday, 11 December 2013

130857BR


Over The Counter
Over The Counter
USA
Parsippany, NJ
Novartis Consumer Health
Production
Full Time
Regular
POSITION SUMMARY

Prepare complaints case reports in accordance with Health Authority requirements and SOPs

KEY RESPONSIBILITIES

• Incorporate investigation results obtained from TPOs into CRTS
• Ensure that potential and determined root causes are addressed with appropriate CAPA
• Carry out Lot trend analysis and Product Family trend analysis for complaints
• Review associated batch records
• Ensure correctness of product information and Call Center intake information
• Incorporate retain and customer return sample inspection results
• Review and incorporate deviation and other quality incident results
• Interact with Call Center to resolve questions
• Serve as QA review for peer-prepared cases
EDUCATION

Bachelor of Science Degree in Chemistry, Pharmacy, Biology, or Related Science or equivalent experience

EXPERIENCE

• 5+ years relevant experience in a regulated Pharmaceutical environment, including complaints handling experience
• Fundamental working knowledge in cGMPs, Quality Systems, analytical chemistry, manufacturing processes, and packaging processes
• Proficiency with computer applications including Microsoft Word, Excel, and PowerPoint.

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