Regio Leiden, Netherlands
Compliance Specialist Narcotics
Onze klant is een organisatie in de farmaceutische industrie gelegen in de provincie Zuid-Holland.
Do you have? Bachelor degree in Supply Chain Management
Do you have? Knowledge of GMP and GDP
Do you have? Experience or affinitiy with a pharmaceutical, biologics manufacturing or distribution environment
Do you speak? Good English and Dutch (written and spoken)
Our client is one of the largest producer of inhaled anesthetics and a global player in hospital generics.
In this coordinating role you're main responsibility will be validating and managing import and export licenses of narcotics in order to make sure of a uninterrupted supply chain for the European market.
- Manage the submission, maintenance, and controlled substance filings for all EU PCC applications, licenses, and registrations. You will update and remove drug codes and or drug schedules from licenses
- Apply for all required import/export narcotics licenses in the EU and elsewhere
- Maintain quotas of controlled substances and proper accountability of controlled substances
- Prepare all required submissions and reports to appropriate regulatory agencies in a timely manner
- Develop, monitor and enforce procedures to prevent material diversion ensure that all activities are controlled through approved procedures
- Host regulatory controlled audits (twice a year)
- Review and audit batch records, packaging and supply documents
- Assist Sales in determining licenses required for new distributors and countries
- Track and maintain a controlled substances inventory for compliance reporting
- Track and complete all reporting requirements from all appropriate EU regulatory bodies
- Insure that business processes and conduct of PCC regarding production, storage, handling, sales and distribution of narcotics are compliant with the local and international regulations
- Coordinate and manage the updates of the narcotic site license(s) addressed to the local health authorities regarding production, sales & distribution of narcotics
- Implement CAPAs and remediation plans on deviations as required
- Assure a good cooperation between the narcotic department and the health authorities
- Work close with QA and logistics ensure all shipment data is reported successful
- Bachelor or Master degree in Supply Chain Management or equivalent
- Experience in a pharmaceutical, biologics manufacturing or distribution environment is an advantage
- Knowledge of GMP and GDP
- Good in English and Dutch (written and spoken).
- Computer skills: MS Office, Excel, PDF
- Knowledge on the GS1 standards e.g. GTIN, NTIN, GLN, SGTIN
For more information you can contact Rutger Koning at firstname.lastname@example.org / +31 85 444 650