Ensure adherence to all federal, state, and local regulations regarding the handling and management of controlled substances.
Develop, implement, and maintain SOPs related to controlled substance management.
Oversee the inventory control processes for controlled substances, including ordering, storage, consumption, and disposal.
Maintain and update necessary records and documentation of control substances to meet regulatory standards.
Prepare and submit control substance accountability to regulatory team on quarterly basis.
Co-ordinate with regulatory team for obtaining the import certificate (IC) and allocation of quota for control substance.
Ensure all processes and procedures are compliant with regulatory requirements and best practices.
Conduct regular audits and reconciliations of controlled substance inventory. Implement and manage tracking systems to ensure accurate inventory records.
Collaborate with cross-functional teams to address and resolve compliance issues.
Manage SAP system and create purchase request (PR) as per business requirements.
Arranged quotation for all the working standards and resources required in Bioanalytical Lab
Ensure adequate resources & logistics are requested to project and availability followed up to closure.
Coordinate with procurement team to ensure purchase order is adequate to send to vendors.
Ensure accurate data entry and maintenance of material inventory information within the SAP system.
Co-ordinate with procurement team for new vendor registration.
Co-ordinate with HOD in preparation of Capex and Opex AOP.
Coordinate with QA team for new vendor audit.
Follow up with vendor for timely delivery of material.
Timely reservation of material against project.
Your experience and qualifications
B.Sc, M.Sc OR M.Pharm
6 to 10 Years of expereince into SAP related activities in Control Substance Mgmnt.