QUALITY CONTROL COMPLIANCE MANAGER

For our client, an international CDMO pharmaceutical company focused on finish products, we are looking for a:

 

QUALITY CONTROL COMPLIANCE MANAGER

 

The position, reporting to the Quality Unit Director and managing a team of resources, will have the following responsibilities:

 

  • Ensuring that Quality Control Operations meets cGMP and regulatory compliance while respecting Regulations, Corporate Standards and Clients requirements
  • Promoting proper and proactive business partnership between QC and the other functions and facilitating QC systems and organization development
  • Managing the QC Compliance teams to ensure that activities and documents are correctly and timely managed for the following items:
  • QC technical documentation 
  • Analytical reference standards and reagents
  • Reference and retention samples
  • Qualification, calibration and maintenance of analytical equipment 
  • Stability studies
  • Investigation of complaints
  • Managing/coordinating specific projects in the QC areas
  • Promoting and supporting training activities in the QC labs
  • Collaborating with the CQ Manager to ensure that lab operations meet cGMP requirements and regulatory compliance; promoting the activities of gap analysis versus the GMP regulations updating and new guidelines requests, contributing to the related plan elaboration, including the definition and the monitoring of the proper corrective actions.

 

Profile:

  • Scientific Degree
  • Previous experience in Quality Control function and in management role
  • Excellent interpersonal written and oral communication skills
  • Ability to coordinate, contribute to and work within a crossfunctional team
  • Ability to work in a dynamic and fastpaced environment

 

Business unit
Quality Unit
Sedi
Italia/Lombardia/Milano

CONTATTI

Pharma Point Srl - Foro Buonaparte, 48 - 20121 Milano, Italia

Email: info@pharmapoint.it - Tel. +39 02-89013167

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