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  • Location

    ZUID HOLLAND, Netherlands

  • Job title:

    Compliance Specialist Narcotics

  • Sector:

  • Job type:

    Permanent

  • Job ref:

    43154

Compliance Specialist Narcotics

The company

Our client is one of the largest manufacturing companies in the world.

Role description

You're main responsibility will be validating import and export licenses of PCC narcotics in order to make sure of a uninterrupted supply chain.

Responsibilities

  • You will update and remove drug codes and or drug schedules from licenses.
  • You will apply for all required import/export narcotics licenses in the EU and elsewhere.
  • You will maintain quotas of controlled substances and proper accountability of controlled substances.
  • You will prepare all required submissions and reports to appropriate regulatory agencies in a timely manner.
  • You will develop procedures to ensure that all activities are controlled through approved procedures.
  • You host regulatory controlled audits twice a year.
  • You will assist Sales in determining licenses required for new distributors and countries.
  • You will track and maintain a controlled substances inventory for compliance reporting.
  • You will Implement CAPAs and remediation plans on deviations as required.
  • You work close with QA and logistics ensure all shipment data is reported successful.

Requirements

  • You have at least 3 years experience in a similar role in the a pharmaceutical or biologics environment
  • You have strong knowledge of GMP and GDP 
  • You have a bachelor degree in management or life sciences 
  • You have experience with SAP 
  • You are fluent in English. German, French or Italian would be an advantage.
  • You have a strong knowledge on the GS1 standards e.g. GTIN, NTIN, GLN, SGTIN

If you are interested in this role, please contact me at e.wienen@sire-search.com or at +31 20 658 98 00.

 

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