Full-time Assistance for Capa Management" - Windsor, CO, United States - Emerald Enterprises

Emerald Enterprises
Emerald Enterprises
Verified Company
Windsor, CO, United States

2 days ago

James Miller

Posted by:

James Miller

beBee Recruiter
Freelance
Description

For our client, an international pharmaceutical company, we are currently seeking a full-time Assistant for CAPA Management in Windsor, CO.

Responsibilities:

  • Systematic tracking and filing of CAPAs to ensure timely implementation and closure
  • Coordination of planned CAPA activities with relevant CAPA stakeholders (pharmacovigilance and nonpharmacovigilance)
  • Collection of implemented points
  • Review/quality control of evidence to ensure compliance with the CAPA plan
  • Support in the development and/or implementation of the CAPA strategy
  • Maintenance of the pharmacovigilance system master file (PSMF)
  • Organization and coordination of activities related to training department members
  • Support for the quality management team in special projects

Requirements:

  • Knowledge in the field of quality management (GxP)
  • Experience in handling/processing (pharmacovigilance) CAPAs or alternatively an experienced (pharmacovigilance) auditor/inspector
  • Demonstration of effectiveness in collaborating with various functions and partners in a multidisciplinary and mixed environment
  • Experience working with the PSMF
  • Knowledge of GxP training requirements
  • Fluent oral and written communication skills in English
  • Good knowledge of European PV legislation

Benefits:

  • Permanent employment
  • Individual allowances such as travel expenses
  • Exciting tasks in a multicultural environment
  • Modern workplace in a convenient location in Windsor, CO
  • A
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