Responsible Person (RP) – Pharmaceutical Wholesale
Part-Time / Flexible | Newly Established Pharmaceutical Company
We are a newly established pharmaceutical company currently in the early stages of planning, setup and our regulatory application process.
We are looking for an experienced and suitably qualified Responsible Person (RP) to join us and support the development of our pharmaceutical wholesale operation.
About the Role
This is not a full-time position. The role is designed to be flexible and would be suitable for an experienced RP who is already working full-time elsewhere or currently acting as an RP/consultant for another organisation.
At this stage, the company is still in the application, planning and setup phase, so the initial time commitment is expected to be relatively limited.
As the business progresses towards becoming operational, the RP will work closely with the directors to ensure that appropriate systems, procedures and processes are established in line with Good Distribution Practice (GDP) and relevant MHRA requirements.
Key Responsibilities
Responsibilities will include, where applicable:
* Supporting the company during the setup and regulatory application stages
* Advising on GDP requirements and regulatory compliance
* Assisting with the development and review of the Pharmaceutical Quality System (PQS)
* Reviewing and approving relevant SOPs and procedures
* Ensuring appropriate processes are in place for storage, transportation and distribution of medicinal products
* Providing oversight of supplier and customer qualification processes
* Supporting processes relating to returns, recalls, complaints and product quality issues
* Providing guidance on temperature control, excursions and transportation requirements
* Ensuring appropriate documentation and records are maintained
* Supporting preparation for regulatory inspections
* Carrying out the responsibilities associated with the RP role once the company becomes operational
Candidate Requirements
We are looking for someone who:
* Has previous experience acting as a Responsible Person (RP) within pharmaceutical wholesale/distribution
* Has strong knowledge of UK GDP requirements and MHRA expectations
* Understands the requirements associated with pharmaceutical wholesale operations
* Has experience with Quality Management Systems and SOPs
* Is organised, reliable and comfortable providing regulatory guidance to a growing business
* Is able to work independently and communicate effectively with the company’s directors and management team
Experience supporting a new Wholesale Distribution Authorisation (WDA(H)) application or setting up a pharmaceutical wholesale business would be highly desirable.
Working Arrangement
This is a part-time, flexible role and does not require the successful candidate to leave their existing employment.
We understand that many experienced Responsible Persons already work within the pharmaceutical industry, and we are happy to discuss a flexible arrangement that can be managed alongside an existing full-time position, subject to there being no conflict of interest or restrictions from your current employer.
The initial workload is expected to be relatively light while the company is in the setup/application stage, with involvement increasing appropriately as the business becomes operational.
Job Type: Part-time / Consultancy / Flexible
Schedule: Flexible
Salary/Rate: Negotiable depending on experience and level of involvement
If you are an experienced Responsible Person and would be interested in supporting a newly established pharmaceutical company from its early stages through to becoming fully operational, we would be very happy to hear from you.
Please apply with your CV and a brief overview of your current RP/GDP experience.
Work Location: Hybrid remote in West London W12
