The Good Distribution Practices Responsible Person (GDP RP) is responsible for safeguarding the beneficiaries of the pharmaceutical products we procure in our programmes against potential hazards arising from poor distribution practices. The Responsible Person should have personal knowledge of the products traded under the licence and the conditions necessary for their safe storage and distribution.
As the Good Distribution Practices Responsible Person (GDP RP) you will have access to all areas, sites, stores, staff and records relating to the licensable activities being carried out at Sightsavers and will review and monitor all related people and areas and the standards of compliance achieved. You will focus on the management of licensable activities, the accuracy and quality of records kept across the organisations and programme partners, compliance with standard operating procedures as laid out in our Quality Management System (QMS) and Good Distribution Practices rules and the quality of handling and storage equipment and facilities.
Other responsibilities include:
- auditing and reporting on systems and sites
- ensuring the provisions of the Licence are observed
- implementing and maintaining a quality management system
- coordinating and performing any recall operations
- approving any subcontracted activities which may impact on Good Distribution Practice
- advising on any additional regulations, introduced by the MHRA or the EU
- supporting compliance and assurance related activities that are undertaken by the global compliance team
- safeguarding and special investigations into allegations of malfeasance, possibly including financial irregularity, terrorism financing, bribery, the abuse of vulnerable people and modern slavery
As the successful candidate you will:
- have experience and knowledge Good Distribution Practices, e.g. ECA Academy courses
- be registered with the MHRA as a “Responsible Person for WDA(H)”
- demonstrate relevant knowledge and experience related to the distribution of medicinal products
- have strong relevant practical and managerial experience of medicinal products, ideally as a pharmacist or Qualified Person (QP)
- be able to design, implement and deliver a programme of activity across the organisation efficiently and effectively
- demonstrate the ability to write persuasive and evidence-based reports
- be fluent in English and ideally French
- be available to travel between 8 – 15 weeks a year
In addition, you should be able to demonstrate understanding of:
- the role of the MHRA in the licensing of medicines and as the competent authority including the risk-based inspection process, the role of the enforcement group, the inspection action group (IAG), and resulting actions that can be taken due to non-compliance
- the UK regulations in relation to wholesale distribution
- the European pharmaceutical directive related to wholesale distribution of medicinal products
- the role of the professional bodies and organisations that regulate those supplying medicinal products to the public e.g. the General Pharmaceutical Council (GPhC)
- the role of the European Medicines Agency (EMA) and use of EUDRAGMDP
- the principles and guidelines of good manufacturing practice and how the principles of GDP maintain product quality throughout the distribution chain
The role of Good Distribution Practices Responsible Person (GDP RP) is highly involved and varied and this is not an exhaustive list of responsibilities or required skills. Please see the Job Description for complete details.
Advert close date: 22nd December 2019
Interviews are expected to be held in the first week of February
As an equal opportunities employer we actively encourage applications from all sections of the community. Qualified persons with disabilities are particularly encouraged to apply.
Sightsavers is not willing to accept unsolicited agency resumes, we are therefore unable to adhere to any terms of business related to unsolicited resumes.