ВеликобританияQuality Complaint Specialist
4 нед. назад
40–60 GBP / годВеликобританияOnsite
Support triage, submission, trending and investigation of quality complaints in pharmacy operations.
Обязанности
- We are seeking a detail-oriented Quality Complaint Specialist to support our UK Superintendent Pharmacist and Quality teams across two connected areas of our pharmacy operation: supporting the triage, submission to suppliers, trending and investigation of quality complaints received from patients/customers dispensed commercially licensed medicines sourced from pharmaceutical wholesalers/suppliers, and the quality complaint investigation process for our non-sterile compounding (unlicensed "specials") pharmacy. This role is central to ensuring that every product-quality complaint — whether tied to a licensed dispensed product or a compounded preparation — is captured, investigated, and closed out in a manner that satisfies MHRA expectations, the Human Medicines Regulations 2012 (including the Article 10/Section 10 exemption framework for unlicensed specials), and our internal Pharmaceutical Quality System (PQS). You will work closely with the Superintendent Pharmacist, Responsible Pharmacists, Quality Control Teams, compounding staff and Pharmaceutical wholesalers/suppliers to ensure patient safety, regulatory compliance, and continuous improvement are at the centre of everything we do.
- 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 (e.g., potential recall, MHRA Yellow Card, or Defective Medicines Report Centre notification) is required.
- Lead and/or support end-to-end complaint investigations, including root cause analysis, batch/lot traceability, retained sample review, where applicable, and liaison with the originating pharmaceutical supplier or wholesaler where the complaint concerns a commercially sourced product.
- Support complaint investigations specific to non-sterile compounded preparations, ensuring alignment with MHRA guidance on unlicensed medicines ("specials"), Human Medicines Regulations 2012 (Article 10/Regulation 3, Schedule 1 exemptions), and applicable professional standards (GPhC, RPS non-sterile compounding guidance).
- Draft clear, well-evidenced investigation reports and CAPA (Corrective and Preventive Action) plans, when applicable; track CAPAs to timely closure and verify effectiveness.
- Maintain accurate, audit-ready documentation in line with Good Documentation Practice (GDP), including complaint files, correspondence with patients/prescribers/suppliers, and trending data.
- Identify and report trends in complaint data to the Superintendent Pharmacist and Quality leadership, flagging recurring issues that may indicate a systemic quality or supply issue.
- Support the Superintendent Pharmacist in maintaining the pharmacy's compliance with MHRA inspection readiness, GPhC standards for registered pharmacies, and relevant SOPs governing complaint handling, deviations, and non-conformances.
- Assist with drafting, reviewing, and revising SOPs related to complaint handling, non-conformance management, and supplier quality as it relates to complaint handling for both the dispensing and compounding operations.
- Liaise with pharmaceutical suppliers and wholesalers to ensure appropriate records are available as necessary to close out applicable complaint investigations, when necessary.
- 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.
Требования
- 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 the 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 professional guidance on unlicensed specials).
- Strong root cause analysis and CAPA experience; comfort applying structured investigation methodologies (e.g., 5 Whys, fishbone/Ishikawa).
- Excellent written communication skills, with the ability to produce clear, defensible investigation reports for regulators, auditors, and internal stakeholders.
- 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.
- We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.
- Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.
- It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
- To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement .
Другое
- 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. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.
- Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit and. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit.