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Quality Manager III
Ref No.: 18-06371
Location: Raritan, New Jersey
Position Type:Engg
Start Date / End Date: 06/04/2018 to 11/16/2018
 
 Job Title: Quality Manager III
Duration: 5+ months
Location: Raritan, NJ- 08869

Job Description:

Business Quality Manager II
 
  • The purpose of this position is to support quality activities for Business Quality including product quality complaints, change control, internal audit/ supplier audits.
  • Process day-to-day product quality complaint (PQC) in Trackwise system including evaluating PQC, assigning investigation, conducting investigation, writing investigation summary. Proactively manage PQCs workflow with stakeholders to ensure all investigations are completed in a timely manner. (25%)
  • Create query and report of PQCs from Trackwise for all products and provide in-depth data analysis of complaint information and trending.
  • Review medical information requests from database and provide in-depth data analysis (25%)
  • Process day-to-day change control records in Trackwise system (25%)
  • Coordinate internal and/or supplier audits including setting up logistic / preparation for the audits, drafting audit plan, supporting audit execution, coordinating audit response and CAPA with stakeholders, creating and documenting audit records in Trackwise system.
  • Ensure all audit commitments are delivered on time (25%)
 
Qualifications:
 
Required: BA/BS – Technical / Life Science
 
At least 4 to 5 years' experience in the Pharmaceutical or related industry;
  • Up-to-date knowledge of relevant pharmaceutical legislation and GMP/GDP
  • Experience working in the quality organization
 
Volume or unit measure of job duties:
  • 20 PQCs / month
  • 15 change control/ month
 
Equipment usage and abilities needed:
  • Highly experienced in Trackwise system, generating query and report, and data analysis with Excel spreadsheet


Apply on-line for immediate consideration, please send your updated resume and contact info via
 Contact: Rashmi M
Email: rashmi@sunrisesys.com | Phone: 732 272 0331