Freelance/Contract Responsible Person/RP/RPI

Posted 10 Days Ago
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Hiring Remotely in United Kingdom
Remote
Senior level
Healthtech • Consulting • Pharmaceutical
The Role
Act as the UK Responsible Person (RP/RPI) to establish and manage a WDA/GDP license: lead QMS training, support and lead MHRA inspections, manage storage/cold chain, provide ongoing RP duties (approx. 1 day/week) and be onsite for inspections and key activities.
Summary Generated by Built In

For the past 25 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. 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 have just established a new partnership with a client based in central London who are looking to achieve their WDA/GDP license. This project is to commence in the next few weeks; it will run for at least a year with a high chance of renewing and it will require more hours in the initial stages to successfully be ready to pass all inspections/gain the license. Following this, ongoing support (acting as their RP) will be around 1 day per week and the individual will be the lead for their storage facility so regular trips to London are a must. We are therefore looking to collaborate with an independent Responsible Person who can ideally commute to central London within 1 to 1 hour 15 minutes on a regular basis.

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 working with Pharmaceutical products

  • 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 the next few weeks with more hours needed in the initial stages

  • Thorough understanding of the GDP landscape in the UK is a must

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.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Skills Required

  • University degree in Pharmacy or suitable discipline
  • Demonstrated exposure working as RP/RPI
  • Experience managing storage and cold chain aspects
  • Thorough understanding of UK GDP landscape
  • Ability to commence within a few weeks and provide increased hours during initial phase
  • Be onsite for key inspections and training activities
  • Skilled in RP/RPI work with pharmaceutical products
  • Regular trips to London to lead the storage facility (ability to travel weekly)
  • Commute to central London within ~1 to 1 hour 15 minutes (ideal)
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The Company
HQ: Raleigh, NC
2,059 Employees
Year Founded: 2001

What We Do

ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies. With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science

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