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PDS Deviations & Client Quality Specialist

LOCATION:
Italy - Ferentino

JOB DESCRIPTION:

Based on PDS project plans and lead by PDS Deviations & Client Quality Specialist the main activities are:

  • Revision of the Patheon PDS-Customer Quality Agreements
  • Revise, from a compliance point of view, the Master Batch Record
  • Perform the review of Executed Master Batch Record
  • Issue Raw materials and primary packaging specifications
  • Issue Product Specification File
  • Perform investigation for Deviations and Complaints
  • Follow the implementation of CAPAs, identified together with SMEs) and their effectiveness over the time
  • Collect and prepare the package to support QP in Batches Release
  • Actively attend to T-call
  • Actively partecipate to Client and Regulatory Audits
  • Issue Quality System SOPs link to PDS environment
  • Issue Annual Product review

REQUIREMENTS:

  • Degree in Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering Engineering.
  • GMP, Pharma background, manufacturing of sterile products.
  • Fluent English
  • 2 years in a similar role

 

Degrees of interest: Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering Engineering.

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