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Qualified Person (QP) & Quality Management System (QMS) Lead
Role Overview
Qualified Person (QP) & QMS Lead – Pharmaceutical
Location: Hatfield, Hertfordshire
Level: Senior / Leadership
Our client, an established international pharmaceutical organisation, is looking for an experienced and UK-registered Qualified Person (QP) to join their UK operation as QP & Quality Management System (QMS) Lead.
This is an excellent opportunity for an established QP to take significant ownership of quality and compliance within a growing UK pharmaceutical operation.
Company Information
Industry: Pharmaceutical / Generics
Role Requirements
This is a senior, business-critical position with responsibility for QP batch certification and release, ownership of the UK QMS, GMP/GDP compliance, MHRA inspection readiness and new product launch support.
The successful candidate will act as a named QP under the company’s UK Manufacturer’s/Importer’s Authorisation and will work closely with UK leadership, international Quality and Regulatory teams, external testing laboratories and third-party logistics partners.
Person Specifications
Key requirements include:
– Formally registered and recognised as a Qualified Person (QP) in the UK
– Approximately 15 years’ pharmaceutical QA/QC experience
– Minimum 2–3 years’ active batch release experience as a named QP under an MIA licence
– Strong knowledge of UK/EU GMP, GDP and Human Medicines Regulations
– Experience managing or supporting MHRA inspections
– Strong experience with QMS, deviations, CAPAs, auditing and batch certification
– Generics, pharmaceutical import or third-country manufacturing experience would be highly advantageous
Package
£: Call 01494 818 037
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