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QC Validation Scientist
The closing date is 21 May 2025
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). Employees will transfer to the new employer on the same terms and conditions, which are protected, and their continuity of employment is preserved.
Main duties of the job
Oversee New Product Introduction processes from a QC perspective for products to be manufactured in the MMC, including:
- Analytical method validation (ICH Q2)
- Technology/method transfer
- QC stability testing (ICH Q1)
- Ongoing stability studies
- Sampling plans
Lead the QC reference standards processes, including:
- Routine use and validation of working standards
- Management of reference and retention samples for finished products and raw materials
Implement QC policies to ensure compliance with GMP, support management of contractors for outsourced QC Chemistry work, lead qualification, PPM, and servicing of QC chemistry equipment. Manage laboratory staff, lead training initiatives, and prepare QC documentation such as protocols, reports, SOPs, and stability plans. Perform assessments for the Pharmaceutical Quality System (PQS), including OOS investigations, RCA, QRA, and change control assessments.
About us
The MMC is a purpose-built NHS pharmaceutical production facility at the Northumbria Innovation and Manufacturing Hub, designed to meet the growing demand for high-quality, regionally manufactured medicines. Funded with £30 million from NHS England, it aims to support a sustainable supply chain for critical medicines, especially oncology and high-risk therapies, creating skilled jobs and fostering innovation. The facility will operate under a Manufacturer's Specials Licence and aims for WDA(H) compliance, ensuring adherence to MHRA, GMP, and GDP regulations from day one.
Our core values focus on quality, patient safety, and staff wellbeing. We foster a culture of openness, learning, and continuous improvement, offering staff the opportunity to shape a modern NHS manufacturing unit. Working at the MMC means being part of a forward-thinking, supportive team dedicated to enabling clinical staff to spend more time with patients by delivering safe, ready-to-use medicines.
Job responsibilities
- Perform QC data recording, trending, and statistical analysis for all QC chemistry data, ensuring accuracy and compliance.
- Oversee stability studies and ongoing stability testing programs, including investigational work and validations.
- Ensure analysis of raw materials, packaging components, and finished products aligns with approved QC worksheets and SOPs.
- Demonstrate compassionate and inclusive leadership by engaging, enabling, and empowering team members, promoting ownership of learning and quality improvement, and facilitating collaboration across departments.
Person Specification Qualifications
- Masters degree in a relevant scientific discipline or equivalent experience.
- Eligible for registration with GPhC, HCPC, RSC, RSB, or RPS.
- Postgraduate qualification in Analytical Chemistry or Pharmaceutical Analysis.
- Postgraduate qualification in Quality Assurance or GMP.
Experience
- Post-qualification experience with analytical techniques used in pharmaceutical QC.
- Knowledge of MHRA GMP guidelines and pharmacopeial requirements.
- Experience with analytical method validation (ICH Q2), stability studies (ICH Q1), and laboratory instrument maintenance (HPLC, FTIR, UV-VIS, pH meters, balances).
- Proficiency in data trending, statistical analysis, and laboratory safety standards (e.g., COSHH).
- Experience managing New Production Introduction from a QC perspective, GMP product formulation studies, and using Quality Management Systems.
- Experience with QC testing of sterile medicines, both chemistry and microbiology, aligned with pharmacopeial standards.
- Awareness of developments in pharmaceutical manufacturing and coaching/mentoring practices.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975. A DBS check will be required to verify any criminal convictions.
Northumbria Healthcare NHS Foundation Trust
Full-time, flexible working, compressed hours