DEPUTY RESPONSIBLE PERSON

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Norgine.
Transforming Healthcare, Backed by Over a Century of Expertise.
e have an exciting opportunity for a registered Deputy Responsible Person to join Norgine in Spain, on a 6-month Fixed Term Contract.
he person holding this position will report to the Regional Quality Compliance Manager and be a member of the Global Corporate Quality team.
he core responsibility of the Deputy Responsible Person is to ensure quality oversight and overall responsibility for the compliance of the country Wholesale Dealers Licence and with the EUROPEAN COMMISSION Guidelines of 5 November on Good Distribution Practice of medicinal products for human use.
KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO.
ct as Deputy Responsible Person (RP) on the Norgine Wholesale Distribution licence, in accordance with EudraLex Vol 4 and in particular the EUROPEAN COMMISSION Guidelines of 5 November on Good Distribution Practice of medicinal products for human use.
nsure that legal entities have Wholesale Dealers' licences in place that are compliant with the GDP expectations set out in the EC Guidelines of 5 November on GDP of medicinal products for human use.
nsure Deputy RP duties, as described in the EUROPEAN COMMISSION Guidelines of 5 November 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 products distributed to the market.
Work with the appropriate Norgine governance bodies to develop and agree on a course of action.
·       Maintain an understanding of current and forthcoming legislation that impacts the 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 the 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  Releasing of medicinal products and medical devices to the market from batches received in the warehouse from different suppliers, 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's global process and ensure local requirements are met·       Maintain release trackers