Description
Compensation
£40 – £60
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery.
About the Role:
We are seeking a detail-oriented Quality Complaint Specialist to support our UK Superintendent Pharmacist and Quality teams. This role is central to ensuring that every product-quality complaint is captured, investigated, and closed out in a manner that satisfies MHRA expectations, the Human Medicines Regulations 2012, and our internal Pharmaceutical Quality System (PQS).
You Will:
- Serve as the second point of intake for product-quality complaints relating to dispensed commercial medicines and non-sterile compounded preparations, logging each complaint accurately and promptly in the complaint management system.
- Support the Superintendent Pharmacist in triaging incoming complaints to determine severity, patient safety impact, and whether escalation is required.
- Lead and/or support end-to-end complaint investigations, including root cause analysis, batch/lot traceability, retained sample review, and liaison with the originating pharmaceutical supplier or wholesaler.
- Support complaint investigations specific to non-sterile compounded preparations, ensuring alignment with MHRA guidance on unlicensed medicines and applicable professional standards.
- Draft clear, well-evidenced investigation reports and CAPA plans, when applicable; track CAPAs to timely closure and verify effectiveness.
- Maintain accurate, audit-ready documentation in line with Good Documentation Practice (GDP).
- Identify and report trends in complaint data to the Superintendent Pharmacist and Quality leadership.
- Support the Superintendent Pharmacist in maintaining the pharmacy's compliance with MHRA inspection readiness, GPhC standards, and relevant SOPs.
- Assist with drafting, reviewing, and revising SOPs related to complaint handling, non-conformance management, and supplier quality.
- Liaise with pharmaceutical suppliers and wholesalers to ensure appropriate records are available as necessary to close out applicable complaint investigations.
- Support internal audits and MHRA/GPhC inspections by preparing complaint files, trend reports, and CAPA evidence.
- Escalate any signal of a potential quality defect, adverse reaction, or patient safety risk to the Superintendent Pharmacist without delay.
You Have:
- 3+ years Experience in a pharmacy, pharmaceutical quality, or regulatory affairs role within the UK.
- Working knowledge of the Human Medicines Regulations 2012, including the Article 10 exemption framework for unlicensed "specials," and familiarity with MHRA guidance on complaint handling.
- Understanding of GPhC standards for registered pharmacies and pharmacy professionals.
- Familiarity with non-sterile compounding practices and associated quality/regulatory expectations.
- Strong root cause analysis and CAPA experience.
- Excellent written communication skills, with the ability to produce clear, defensible investigation reports.
- High attention to detail and strong organisational skills, with the ability to manage multiple open investigations against defined timelines.
- Experience with quality management systems (QMS) or complaint-tracking databases preferred.