Ensuring the pharmaceutical warehouse of a European pharmaceutical manufacturer operates in full compliance with local regulatory licensing regulations (import and wholesale) and adheres to Good Distribution Practice (GDP) regulations. Key responsibilities include:

• Record Keeping and Inventory Management:Maintaining meticulous warehouse records and conducting regular inventory checks.
• Regulatory Compliance:Preparing applications to the State Service for Drug Control to obtain quality assessments of imported drugs and facilitating the process from obtaining conclusions to transferring goods from quarantine to sales.Organizing laboratory analyses through accredited laboratories, creating necessary accompanying documentation, and managing contracts with laboratories.Developing and managing quality certificate templates in Ukrainian, as per Cabinet of Ministers Resolution No. 902 and ST-N MOZU 42-4.4:2011.Translating quality certificates and complex documentation accurately and effectively.
• Documentation and SOPs:Drafting over 30 Standard Operating Procedures (SOPs) related to pharmaceutical warehouse processes and product quality assurance.Preparing work instructions, creating printed forms, templates, acts, protocols, logs, and questionnaires for supplier audits.Writing additional agreements for standard supply contracts, reviewing and accepting contracts.Preparing draft orders, letters of guarantee, and information letters.
• Quality Control:Ensuring thorough quality control, sampling, and verification of batch series with registration materials of the Ministry of Health.Interacting with brokers to rectify customs declaration errors.Overseeing temperature control and the maintenance of a suitable temperature regime within the warehouse.Organizing qualification, validation, and verification of warehouse equipment.
• Sales and Distribution:Managing the sales process to pharmaceutical distributors, including order selection, proper assembly, documentation preparation, and shipment control.Ensuring smooth document flow with counterparties.
• Personnel and Training:Regularly training warehouse personnel, developing training programs and test questions, and maintaining training records.
• Sanitation and Hygiene:Overseeing regular sanitary and hygienic visits to the pharmaceutical warehouse, ensuring cleanliness, deratization, and disinfestation.Monitoring employee health and hygiene, including sick leave management.
• Complaint Handling and Disposal:Handling complaints related to factory defects, damage during transportation, and returns of expired or expiring goods.Preparing complaint reports to manufacturing plants and managing incoming reports from distributor customers.Managing the disposal of defective and expired pharmaceutical products, including the associated documentation and reporting.
• Technical and IT:Configuring 1C reports related to warehousing and accounting activities.Writing Visual Basic macros in Excel for data processing.Managing the setup, maintenance, and repair of printing equipment and network/server equipment.
• Surveillance and Audits:Utilizing the warehouse video surveillance system to locate goods sent to the wrong customer.Exporting, cutting, and converting video for dispute resolution and customer complaints.Participating in the opening of a new pharmaceutical warehouse and facilitating licensing requirements and warehouse audits by international auditing firms.

Diligently crafting and submitting applications to secure assessments from the territorial branches of the State Service for Control over Medicinal Products of Ukraine, specifically concerning the quality of imported pharmaceutical and immunobiological products in alignment with the guidelines articulated in Cabinet of Ministers Resolution No. 902. Managing the extensive documentation associated with quality certificates, analytical data, registration materials, and confirmations of compliance with Good Manufacturing Practice (GMP) standards, as well as invoices and customs declarations. Serving as the qualified person for cooperation with the State Expert Center of Ukraine for the laboratory evaluation of imported immunobiological drugs (vaccines). Maintaining daily collaboration with the representative offices of manufacturers, inspectors, and laboratories to address challenges encountered during the quality approval process.

Ensuring strict adherence to the terms stipulated in the pharmacy's licensing agreement. Achieving and surpassing sales targets, particularly non-cash transactions with corporate clients as outlined in contractual agreements. Creating employee schedules for the pharmacy staff. Overseeing the procurement process from pharmaceutical distributors, verifying financial discipline, maintaining meticulous accounting records, and facilitating the sale of pharmaceutical products. Offering expert guidance in the selection and optimization of prescribed treatments while assisting customers in identifying more cost-effective and higher-quality medication alternatives. Conducting periodic inventories to ensure precise stock management within the pharmacy.

Engaging in procurement activities and forging direct supply agreements with pharmaceutical distributors. Managing interactions with the state register of medicines, medical devices, and the register of wholesale prices. Conducting in-depth analyses to assess the viability of purchases with the aim of optimizing profit margins for subsequent resale. Ensuring vigilant oversight of product inventory levels and strategic procurement planning.

Supplying a comprehensive medical facility, with a specific focus on departments such as oncology, intensive care, and surgical units, with pharmaceuticals, medical consumables, and procedural instruments. Establishing and managing a pharmaceutical warehouse for the medical center in accordance with the regulatory framework of Ukraine.