ZENOPA LTD
Qualified Person (QP) & QMS Lead
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Location: Hatfield, Hertfordshire - 5x per week
Industry: Pharmaceuticals
The Opportunity:
Our client is an established international pharmaceutical organisation with a growing UK and European presence. They are seeking a highly experienced, UK-registered Qualified Person (QP) to take responsibility for QP batch certification and lead the UK Quality Management System.
This is a senior and highly accountable position, responsible for ensuring the quality, safety and regulatory compliance of medicinal products entering the UK market.
Working closely with UK senior leadership and international Quality, Regulatory, Operations and Supply Chain teams, the successful candidate will play an important role in maintaining compliance, supporting new product launches and ensuring continuity of pharmaceutical supply.
Key Responsibilities:
QP Batch Certification & Release
- Fulfil the statutory responsibilities of a Qualified Person under the Human Medicines Regulations 2012.
- Review and certify imported batches of finished medicinal products in accordance with GMP, Marketing Authorisations and UK regulatory requirements.
- Oversee batch certification and final market release for products manufactured outside the UK.
- Ensure appropriate analytical, microbiological and physical testing has been completed prior to release.
- Oversee Analytical Method Transfers between international manufacturing/QC teams and UK or European testing laboratories.
- Review and approve Out-of-Specification results, deviations, investigations and CAPAs.
- Act as RP/RPi for relevant UK/EU activities where required.
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Quality Management System & GDP
- Own, maintain and continuously improve the UK Quality Management System.
- Ensure continued compliance with GMP, GDP and applicable MHRA requirements.
- Lead the development and review of SOPs, Change Controls, Deviations and CAPAs.
- Maintain the QMS in line with evolving UK pharmaceutical regulations.
- Conduct and oversee audits of external manufacturing organisations, laboratories, warehouses, logistics providers and other suppliers.
- Maintain appropriate Quality Technical Agreements with external partners.
- Lead quality complaint and product recall processes, including appropriate MHRA reporting.
- Develop and deliver ongoing GxP training to relevant UK employees.
New Product Launches & Supply
- Lead the Quality workstream supporting new pharmaceutical product launches into the UK.
- Ensure regulatory approvals, manufacturing documentation, testing requirements and batch release documentation are in place ahead of launch.
- Work cross-functionally with Regulatory, Commercial, Quality, Operations and Supply Chain teams.
- Support supply continuity and help minimise the risk of critical stock shortages.
- Review shipping validation, temperature monitoring and relevant customs and quality documentation for imported products.
Qualifications & Experience:
The successful candidate will be required to demonstrate:
- A relevant university degree in Pharmacy, Pharmaceutical Chemistry, Biology, Chemistry or another permitted scientific discipline.
- Formal registration and recognition as a Qualified Person in the UK, eligible to be named on a UK Manufacturer's/Importer's Authorisation.
- Approximately 15 years' experience within pharmaceutical Quality Assurance and/or Quality Control.
- At least 23 years' active batch release experience as a named QP under an MIA licence.
- Strong working knowledge of UK/EU GMP, GDP and Human Medicines Regulations 2012.
- Demonstrable experience supporting and managing MHRA inspections, including responses and remediation of observations.
- Strong knowledge of auditing, analytical and microbiological testing, stability data and analytical method transfers.
- Experience managing deviations, investigations, Change Controls and CAPAs.
- Strong cross-functional communication and stakeholder management skills.
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Desirable Experience
- Experience within a generic pharmaceutical import and wholesale environment.
- Experience managing products manufactured at third-country sites.
- Active GPhC registration or equivalent professional registration in chemistry or biology.
- Experience across oral solid dosage products, sterile products and oral solutions.
- Experience using pharmaceutical ERP and electronic document management systems; SAP experience would be advantageous.
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