QC Validation Scientist

Job overview

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

Main duties of the job

Oversee New Product Introduction processes from a QC perspective for products to be manufactured in the Medicines Manufacturing Centre (MMC). This includes:

• Method development (ICH Q14) Analytical method validation (ICH Q2) Technology/method transfer QC stability testing (ICH Q1) Ongoing stability studies Formulation studies Sampling plans Cleaning validation (residue testing) methods
• Method development (ICH Q14)
• Analytical method validation (ICH Q2)
• Technology/method transfer
• QC stability testing (ICH Q1)
• Ongoing stability studies
• Formulation studies
• Sampling plans
• Cleaning validation (residue testing) methods

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 Good Manufacturing Practices (GMP).

Support the management of contractors for outsourced QC Chemistry work.

Lead the qualification, planned preventative maintenance (PPM), and servicing of QC chemistry equipment.

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.

Prepare and implement QC documentation such as:

• Protocols for stability studies, investigational work, and validations QC reports, worksheets, SOPs, stability plans Statistical analysis
• Protocols for stability studies, investigational work, and validations
• QC reports, worksheets, SOPs, stability plans
• Statistical analysis

Perform assessments for the Pharmaceutical Quality System (PQS), including:

• Out of Specification (OOS) investigations
• Root Cause Analysis (RCA)
• Quality Risk Assessment (QRA)
• QC assessments on Change Control

Detailed job description and main responsibilities

Perform QC data recording, trending, and statistical analysis for all QC chemistry data, ensuring accuracy and compliance.

Oversee the implementation of stability studies and ongoing stability testing programs, including investigational work and validations.

Ensure analysis of raw materials, packaging components, and finished pharmaceutical products is performed in line with approved QC worksheets and SOPs.

Demonstrate compassionate and inclusive leadership, actively shaping a collective leadership culture within the Trust by:

• Engaging, enabling, and empowering others Using coaching to promote ownership of learning and quality improvement Facilitating team working and collaboration across teams, departments, and organisational boundaries
• Engaging, enabling, and empowering others
• Using coaching to promote ownership of learning and quality improvement
• Facilitating team working and collaboration across teams, departments, and organisational boundaries