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JOB DESCRIPTION Job Title: GDP Compliance Senior Executive Department: Quality (London) Reports to: Quality Compliance Manager & RP Number of Reports: Nil MAIN PURPOSE OF ROLE: To ensure the organization abides by the guidelines on Good Distribution Practice (GDP) according to the Quality Management System (QMS) in place, in line with the EU Guidelines on Good Distribution Practice Medicinal Products for Human Use (2013/C 343/01). KEY RESPONSIBILITIES: All distribution activities are inline with the relevant process licenses held within the organisation Direct communication with all third party distributors Lead the investigation and closure of deviations related to GDP activities e.g. Temperature excursion deviations Management and maintenance of system for bona fide checks for direct customers and third party distributors Effective communication with the Quality and cross functional teams KEY ACCOUNTABILITIES: To document and verify the global transportation routes taken for all AMCo products, working closely with the Supply Chain department and external contractors. To assess the temperature monitoring / control requirements for each transportation route. Periodic review of validated transport routes to ensure compliance and adherence. Build and maintain a strong and co-operative relationship with the competent authorities enhancing AMCo's reputation over time To assist in ensuring that an effective QMS is implemented and maintained To assist in the maintenance of AMCo Wholesalers Dealers Authorisation and Controlled drugs licenses. To coordinate the supply of Controlled Drugs inventory information to the Home Office. To assist in the coordination and execution of any recall operations of medicinal product in accordance with AMCo procedures. To ensure that GDP relevant customer complaints are dealt with effectively in accordance with AMCo procedures To ensure that adequate and complete records relating to GDP are maintained To approve and deliver the initial and continuous training program in relation to GDP Page 1 of 2 To ensure that all personnel are trained to carry out their respective duties in relation to GDP .To oversee self inspection of the relevant areas of the QMS. To ensure contracts are in place between AMCo and Contract Acceptors relating to distribution activities. To employ due diligence in the discharge of duties and to report to senior management and the relevant EU authority of any awareness of suspicious events or falsified products. To be present during an inspection by the competent authorities To keep up to date with current regulations and industry standards through a program of continuous professional development. GDP Compliance Senior Executive Requirement Essential Desirable Qualifications: B.Sc Science Graduate (Chemistry / Biology / Pharmacy (or close equivalent) M.Sc Experience & Competences Minimum 2 years’ experience of working in a similar role within a pharmaceutical company Candidate should have sound working knowledge of all GDP relevant regulations Experience in controlling and directing the wholesale distribution of medicinal products Registered with the MHRA as Responsible Person on a Wholesalers dealers authorisation Experience of working in a virtual company environment Knowledge & Skills Knowledge of GDP / QMS Good communication skills Investigational skills Decision making & problem solving skills MS office Trackwise Personal Qualities A Methodical, Hardworking individual Specific awareness of Company’s culture and objectives Ability to adapt to change Proactive Ability to adapt to change Date 14.01.2016 Page 2 of 2