Job Title: Qualified Person (QP) – Pharmaceuticals

Location: London, United Kingdom (Onsite)

Work Arrangement: Onsite – Plant / Quality Office (No remote work)

Work Schedule: Standard business hours (Full onsite presence required)

Employment Type: Full-Time | Permanent

Role Overview

We are seeking an experienced Qualified Person (QP) to ensure that medicinal products released to the UK and EU markets comply with UK law, EU Directives, GMP requirements, and Marketing Authorisation conditions.

The QP will act as the single accountable authority for batch certification, quality compliance, and regulatory readiness, working closely with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain teams.

Key Responsibilities

I. Batch Certification & Manufacturing Compliance

• Certify batches in accordance with UK law, EU GMP, and Directive 2001/83/EC
• Ensure manufacturing activities comply with Marketing Authorisation requirements
• Act as the final decision-maker for batch release to the UK/EU market

II. Importation & Product Release (EU/UK)

• Schedule and manage quantitative and qualitative analysis of imported products
• Review and approve Certificates of Analysis and batch documentation
• Ensure retention samples and reference samples are stored and tracked per regulations
• Monitor validation status of manufacturing and QC testing processes
• Support resolution of product quality issues for UK/EU markets through cross-functional collaboration

III. Quality Systems & Documentation

• Maintain and oversee QP Registers or equivalent systems for batch certification
• Review and maintain documentation including:
• Annual Product Reviews (APR)
• Quality Management Reviews
• Deviations, CAPAs, Change Controls, Risk Assessments
• Self-inspection reports
• Ensure Quality Agreements with third parties comply with GMP expectations

IV. Regulatory Compliance & Quality Governance

• Act as the primary point of contact for quality, compliance, recalls, and inspections
• Ensure corporate quality policies and local regulatory requirements are fully implemented
• Drive SOP development and maintenance aligned with current UK/EU guidelines
• Plan and monitor GMP and SOP training for relevant employees

V. Regulatory Intelligence & Management Advisory

• Stay current with changes in UK, EU, and MHRA regulatory frameworks
• Advise senior management on quality, compliance, and patient safety risks
• Support interactions with MHRA for manufacturing lines and product approvals

VI. Qualified Person Accountability

• Act as Named Qualified Person following QP approval
• Perform all statutory QP duties in compliance with UK and EU regulations

Required Qualifications

Education

• Degree in Pharmacy, Chemistry, Biology, or a related scientific discipline

Eligibility

• Must be eligible to act as a Qualified Person under UK law (Directive 2001/83/EC)

Experience

• 4–5+ years of experience acting as a Qualified Person (QP)
• Strong background in pharmaceutical manufacturing and quality assurance
• Experience working within large or complex pharmaceutical organizations
• Solid understanding of GMP, EU regulations, and batch release requirements

Key Competencies

• Expert knowledge of EU & UK GMP regulations
• Strong decision-making authority and integrity
• High attention to detail and risk awareness
• Excellent communication and stakeholder management skills
• Ability to work independently in a highly accountable role

Work Environment

• Based at a manufacturing site or corporate quality office
• Close collaboration with QA, Manufacturing, Regulatory Affairs, and Supply Chain teams
• Reports into UK Quality Leadership