Quality Complaint Specialist

About This Opportunity

Our talent team at Get A Job.ai is representing a confidential healthcare organization in their search for a Quality Complaint Specialist based in London, England. This position sits at the intersection of patient safety, regulatory compliance, and quality assurance within a pharmacy operation that handles both commercially licensed medicines and non-sterile compounding.

You will support the UK Superintendent Pharmacist and Quality teams in managing the end-to-end complaint lifecycle—from initial triage and root cause investigation through to CAPA implementation and regulatory reporting. This is a critical role for ensuring MHRA compliance, GPhC standards adherence, and continuous improvement across the pharmacy operation.

Responsibilities

• Log and triage product-quality complaints for both dispensed commercial medicines and non-sterile compounded preparations in the complaint management system
• Support the Superintendent Pharmacist in assessing complaint severity, patient safety impact, and escalation requirements (including potential recalls, MHRA Yellow Card submissions, or Defective Medicines Report Centre notifications)
• Lead end-to-end complaint investigations, including root cause analysis, batch traceability, retained sample review, and liaison with pharmaceutical suppliers or wholesalers
• Conduct investigations specific to non-sterile compounded preparations in alignment with MHRA guidance on unlicensed medicines and Human Medicines Regulations 2012 (Article 10/Regulation 3, Schedule 1 exemptions)
• Draft investigation reports and CAPA plans; track corrective actions to closure and verify effectiveness
• Maintain audit-ready documentation in line with Good Documentation Practice, including complaint files, correspondence, and trending data
• Identify and report trends in complaint data to flag recurring issues that may indicate systemic quality or supply concerns
• Support MHRA inspection readiness and GPhC compliance by maintaining appropriate SOPs and documentation
• Liaise with pharmaceutical suppliers and wholesalers to gather necessary records for complaint closure
• Assist with internal audits and regulatory inspections by preparing complaint files, trend reports, and CAPA evidence
• Escalate any potential quality defects, adverse reactions, or patient safety risks immediately to the Superintendent Pharmacist

What We're Looking For

• 3+ years of experience in pharmacy, pharmaceutical quality, or regulatory affairs within the UK, ideally in 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
• Familiarity with MHRA guidance on complaint handling, recalls, and Defective Medicines Reporting
• Understanding of GPhC standards for registered pharmacies and pharmacy professionals
• 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 (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 organizational skills with the ability to manage multiple open investigations against defined timelines
• Experience with quality management systems (QMS) or complaint-tracking databases preferred

How We Work with You

When you apply through Get A Job.ai, our recruiting team will review your qualifications and conduct an initial screening. If there's a strong match, we'll submit your profile to our client for consideration. Please note that all applications must go through Get A Job.ai—we ask that you do not contact the client organization directly during the recruitment process.

We are committed to supporting candidates throughout the entire process, from initial application through offer negotiation and onboarding.

Pay

Compensation details will be discussed during the screening process with our recruiting team.

Equal Opportunity

Get A Job.ai is committed to inclusive hiring practices and considers all qualified applicants regardless of background. We encourage applications from candidates of all experiences and perspectives.