Company profile
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Position overview
Here at ProPharma we are currently supporting a Biological client as they are looking to establish their new WDA/GDP activities in the UK and require support achieving their licenses. This project will commence within the next 6 weeks; it will run initially for one year but with the aim of continuing to the end of 2027. On average the role would offer 1 day per week throughout the project but with the caveat more time would be required at critical times. The role can be performed largely remotely and travel to the site is only required when critical in performing the role.
In this position, you will act as the RP/RPI for our client in the UK to help them establish a new license and manage it over a long term period. The role will compromise of several aspects which include QMS training; leading key inspections from the MHRA and supporting daily activities associated with the RP/RPI function. You will also be expected to be onsite for key inspections/training activities and ideally you will support other key initiatives as directed by our client.
Qualifications
* A University degree in Pharmacy or suitable discipline in order to be an RP/RPI in the UK.
* Must have demonstrated exposure working as RP/RPI
* Ideally skilled in working as an RP/RPI with Biological products
* Accredited to the ‘Gold standard, RPI’ would be highly preferred
* Experience of managing storage/cold chain aspects is also required
* Can perform the position requirements as set out in the job description
* Can commence a new project in mid-October
* Thorough understanding of the GDP landscape in the UK is a must
Additional information
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.**