QC Validation Scientist

Northumbria Healthcare NHS Foundation Trust; Seaton Delaval; On-site; GBP 35,000 - 50,000; Full time

Job summary

An exciting opportunity for a Quality Control Validation Scientist at the Medicines Manufacturing Centre in Seaton Delaval. Join a pioneering NHS pharmaceutical production facility focused on quality, innovation, and patient care. Responsibilities include overseeing QC processes, managing staff, and ensuring compliance with GMP. Be part of a supportive team dedicated to delivering safe, ready-to-use medicines.

Qualifications

• Experience in overseeing QC processes and method development.
• Leadership in managing QC laboratory staff and training initiatives.

Responsibilities

• Oversee New Product Introduction Processes from a QC Perspective.
• Implement QC policies to ensure compliance with Good Manufacturing Practices.
• Manage the chemistry laboratory staff and lead training initiatives.

Skills

Quality Control

Analytical Method Validation

Good Manufacturing Practices

Root Cause Analysis

Quality Risk Assessment

Job description

An exciting opportunity has arisen for a proactive and passionate Quality Control Validation Scientist to join the Medicines Manufacturing Centre (MMC)—a cutting-edge NHS pharmaceutical production facility based in Seaton Delaval, Northumberland. The MMC is in its final design stages, with facility construction planned through to September 2025. This is a fantastic opportunity to be part of a pioneering NHS manufacturing facility, supporting a leadership team committed to quality, innovation, and patient care. Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received.

All employees of the Medicine Manufacturing Centre (MMC) are currently employed by Northumbria Healthcare NHS Foundation Trust, under Agenda for Change Terms and Conditions. Should the service be transferred into alternative ownership, those employees with start dates prior to the transfer date, will be protected under Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE). Therefore, employees will transfer to the new employer on the same terms and conditions, which are protected and the employees’ continuity of employment is preserved.

Key Responsibilities:

1. Oversee New Product Introduction Processes from a QC Perspective for products to be manufactured in the MMC, including method development (ICH Q14), analytical method validation (ICH Q2), technology/method transfer, QC stability testing (ICH Q1), ongoing stability studies, formulation studies, sampling plans, and cleaning validation (residue testing) methods.
2. Lead the QC Reference Standards processes, including routine use and validation of working standards, and management of reference and retention samples for finished products and raw materials.
3. Implement QC policies to ensure compliance with Good Manufacturing Practices (GMP).
4. Support the management of contractors for outsourced QC Chemistry work.
5. Lead the qualification, planned preventative maintenance (PPM), and servicing of QC chemistry equipment.
6. Manage the chemistry laboratory staff on a day-to-day basis and for long-term planning. Lead training initiatives for QC scientists in relevant QC methods.
7. Prepare and implement QC documentation such as protocols for stability studies, investigational work, validations, QC reports, worksheets, SOPs, stability plans, and statistical analysis.
8. Perform assessments for the Pharmaceutical Quality System (PQS), including Out of Specification (OOS) investigations, Root Cause Analysis (RCA), Quality Risk Assessment (QRA), and QC assessments on Change Control.

About MMC:

The Medicines Manufacturing Centre (MMC) is a brand-new, purpose-built NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. Established to meet the growing need for high-quality, regionally manufactured Ready-to-Administer (RtA) medicines and advanced aseptic products, it is part of the North East and North Cumbria Provider Collaborative.

Funded with £30 million of investment from NHS England, the MMC supports a secure, sustainable supply chain for critical medicines, especially oncology and high-risk therapies. The facility is designed to operate under a Manufacturer’s Specials Licence (MS) and aims to secure a Wholesale Dealer’s Authorisation (WDA(H)), ensuring compliance with MHRA, GMP, and GDP regulations from day one.

At the MMC, quality, patient safety, and staff wellbeing are at the heart of everything we do. Our leadership team is committed to fostering a culture of openness, learning, and continuous improvement—offering staff a unique opportunity to shape the systems, teams, and values of a modern NHS manufacturing unit.

Working at the MMC means being part of a forward-thinking and supportive team dedicated to enabling frontline clinical staff to spend more time with patients by delivering safe, ready-to-use medicines.

Contact:

For further details or informal visits, contact:

• Name: Carly McGurty
• Job Title: Deputy Head of Quality
• Email: [e-mail]