673. Técnico Responsable

Act as Deputy Responsible Person (RP) on the Norgine Wholesale Distribution licence, in accordance with EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.

Ensure RP duties, as described in EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use are performed or appropriately delegated to suitably trained personnel (without delegating responsibility).

·       Ensure staff with delegated duties are appropriately trained and understand the importance of their delegated duties

·       Ensure appropriate documentation of delegated duties;

·       To identify and report to senior management any events of defective or inappropriate product distributed to market. Work with the appropriate Norgine governance bodies to develop and agree a course of action.

·       Maintain an understanding of current and forthcoming legislation that impacts distribution of pharmaceutical products;

·       To maintain an understanding of current product licence requirements;

·       Ensure oversight of outsourced distribution activities and appropriate qualification and monitoring of involved Third parties;

·       Ensure that authorised activities (including export and transport) are managed and records are accurate and compliant; ensure that customer complaints are appropriately recorded and handled according to Site and Global SOPs;

·       Ensure that suppliers and customers involved in any outsourced activity which may impact on GDP are qualified and in approved status according to Norgine qualification program; monitor and review their performance to identify and implement any required improvements;

·       In case a recall for medicinal products is deemed necessary, coordinate and promptly perform any necessary operation

·       Decide independently on the final disposition of returned, rejected, recalled or falsified products; approve any returns to saleable stock;

·       Ensure that a self-inspection plan is in place and any identified required corrective actions are implemented;

·       Coordinate Inspection Readiness activities to ensure adherence to the applicable internal and external standards of compliance at all times.

·       Ensuring that initial and continuous training programs are implemented and maintained to assure competency in GDP

Act as deputy Local Person responsible for Regulatory compliance and ensure the Management and Quality Assurance of the Distribution activity of the medical devices. This person also have accurate knowledge of the legislation and other regulations applicable to medical devices, according local legislation.

Ensure legal entity have Wholesale Dealers licences in place that are compliant with EU Medical Device Regulation 2017/745 of the EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 for Medical Devices.

Releasing of medicinal product and medical devices to the market from batches received in the warehouse from different supplier and prior to distribution

·       Overall responsibility of the process for National Administrative releases

·       Coordinate release activities with supporting GDP colleagues

·       Ensure quality releases are according to Norgine global process and ensuring local requirements are met

·       Maintain release trackers