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Quality Complaint Specialist

Hims & Hers· QUALITY
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London, England£40k - £60kFull-timePosted 1mo ago

About the role

Detail-oriented quality professional supporting UK regulatory-compliant handling of quality complaints for dispensed medicines and non-sterile compounded preparations, ensuring investigations, CAPAs, and reporting meet MHRA, GPhC, and PQS requirements.

Responsibilities

  • Serve as the second point of intake for product-quality complaints relating to dispensed commercial medicines and non-sterile compounded (Article 10 "specials") 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 (e.g., recall, MHRA Yellow Card, or Defective Medicines Reporting).
  • Lead and/or support end-to-end complaint investigations, including root cause analysis, batch/lot traceability, retained sample review, and liaison with suppliers when applicable.
  • Support complaint investigations for non-sterile compounded preparations, ensuring alignment with MHRA guidance and relevant regulations and professional standards.
  • Draft clear, well-evidenced investigation reports and CAPA plans; track CAPAs to closure and verify effectiveness.
  • Maintain audit-ready documentation in line with GDP, including files, correspondence, and trending data.
  • Identify and report trends in complaint data to leadership, flagging recurring issues indicating systemic quality or supply issues.
  • Support compliance with MHRA inspection readiness, GPhC standards, and SOPs governing complaint handling, deviations, and non-conformances.
  • Assist with drafting and revising SOPs related to complaint handling, non-conformance, and supplier quality for dispensing and compounding operations.
  • Liaise with pharmaceutical suppliers and wholesalers to ensure records are available to close investigations when necessary.
  • Support internal audits and MHRA/GPhC inspections by preparing complaint files, trend reports, and CAPA evidence.
  • Escalate any signal of potential quality defect, adverse reaction, or patient safety risk to the Superintendent Pharmacist without delay.

Qualifications

  • 3+ years Experience in a pharmacy, pharmaceutical quality, or regulatory affairs role within the UK, ideally within a dispensing pharmacy, wholesaler, or compounding/"specials" manufacturing environment.
  • Working knowledge of the Human Medicines Regulations 2012, including Article 10 exemption framework for unlicensed "specials", and familiarity with MHRA guidance on complaint handling, recalls, and Defective Medicines Reporting.
  • Understanding of GPhC standards for registered pharmacies and pharmacy professionals, and experience supporting a Superintendent Pharmacist or Responsible Pharmacist in a regulated environment.
  • Familiarity with non-sterile compounding practices and associated quality/regulatory expectations (e.g., RPS guidance).
  • Strong root cause analysis and CAPA experience; familiarity with structured investigation methodologies (e.g., 5 Whys, fishbone/Ishikawa).
  • Excellent written communication skills for clear, defensible investigation reports for regulators and stakeholders.
  • High attention to detail and strong organisational skills to manage multiple investigations with timelines.
  • Experience with quality management systems (QMS) or complaint-tracking databases (preferred).

Skills

Required:Quality complaint handlingRoot cause analysisCAPA managementRegulatory knowledge (UK MHRA, GPhC)Documentation and GDP
Last updated Sep 30, 2026. Interested? Apply on the company site.

About Hims & Hers

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