Comliance Specialist - South Holland - Permanent Position
This organisation is the third largest producer of Inhaled Anesthetics and a global player in hospital generics. They are a worldwide supplier of Critical Care products in more than 100 countries and a market Leader of a muscle relaxant medicine.
Position Overview The European controlled Substances Coordinator is responsible to manage all aspects of controlled substance compliance within the organization. Duties include coordinating the day-to-day activities of the organizations narcotics compliance including import-export license application and management in order to safeguard the uninterrupted supply of narcotics in the supply chain.
- Manage the submission, maintenance, and controlled substance filings for all EU company applications, licenses, and registrations. Update/remove drug codes and or drug schedules from licenses as required.
- Maintain quotas of Controlled substances and proper accountability of all on-hand controlled substances.
- Prepare all required submissions and reports to appropriate regulatory agencies in a timely manner.
- Develop, monitor, and enforce appropriate procedures to prevent material diversion and ensure that all activities are controlled through approved procedures.
- Insure and audit 3PLs and transport companies for controlled substance regulation and procedure compliance.
- Review and audit Batch Manufacturing Records, Packaging and Supply documents for reconciliation purposes as required.
- Track & maintain a controlled substances inventory for compliance reporting; provide monthly reporting on performance measures and statistics; conduct audit checks of the controlled substances program and assess for continuous process improvements
- And more…
- At least 5 years of controlled substance compliance experience working in a pharmaceutical or biologics manufacturing or distribution environment required
- Strong working knowledge of UK, European, GMP, GDP and WHO controlled substance regulations regarding the production, sales and distribution of narcotics. Global knowledge highly desirable.
- Good communication skills, collaboration, and follow through.
- Bachelor's Degree in management or life sciences preferred
- SAP experience preferred.
How to apply?
Interested in working for a new Life Science Company in the region South Holland? Apply now by sending you CV to Shaneequa Ho A Tham, s.hoatham(A)realstaffing.com or contact her via 020 522 15 77.