Our pharmaceutical client has an exciting opportunity for a Technical & Validation Quality Lead to join its team.

Job Summary

The Technical and Validation Quality Lead serves as a technical quality expert, providing guidance, making quality-related decisions, and supporting validation efforts. This role involves collaborating closely with the quality assurance team, overseeing day-to-day operations, and ensuring quality standards are upheld. Key responsibilities include leading technical investigations, managing customer and supplier quality issues, and ensuring compliance with validation processes.

Key Responsibilities & Duties

Technical Leadership

1. Lead Quality Assurance Efforts

• Manage and resolve investigations, including customer responses to technical, product quality, and film coating dispersion complaints.
• Address quality issues promptly, including assessing non-conformities, supplier concerns, and raw material problems.
• Lead 8D investigations for the Dartford site to identify and resolve quality challenges.
• Communicate effectively with customers via written or verbal methods to resolve quality-related issues.
• Identify areas for improvement within the department and business using audit findings and quality metrics; coordinate with relevant departments to ensure timely implementation.
• Support Field Force and customer care teams with technical and quality-related queries.
• Conduct site visits to customers and suppliers to address quality issues and evaluate new systems or processes as needed.

Validation and Compliance

1. Validation and Documentation

• Maintain and update the Site Validation Master Plan, adapting as needed for changes at the Dartford site.
• Generate new regional Project Numbers specific to the Dartford site.
• Oversee the Validation Database within the Oracle system, managing updates during and after project lifecycles.
• Support qualification and validation efforts for QC, plant activities, processes, equipment, and cleaning validation as needed.
• Review and approve validation protocols and reports (except Global Quality Assurance) before final sign-off.
• Ensure regional validation SOPs comply with IPEC/ISO standards.
• Manage the periodic evaluation schedule by updating validation projects in Oracle and tracking the Site Re-Validation Assessment in the Business Intelligence Database.

Key Requirements

• Education: BSc (Hons) in Chemistry, Life Sciences, Food Science, or Materials Science. Ability to understand the science behind the products, their applications, and performance.
• Communication: Strong written and oral communication skills with the ability to prepare and present technical information.
• Technical Leadership: Proven track record in leading technical discussions on product quality and making informed decisions.
• Validation Experience: Experience in validation activities within a healthcare setting, including processes, test methods, cleaning, and FUE.
• Project Management: Strong project planning and resource management skills, with a focus on prioritization.
• Team Leadership: Demonstrated leadership and self-development skills with the ability to work within a matrix organizational structure.
• IT Skills: Proficiency in Excel, Word, and PowerPoint.
• Travel: Occasional travel required based on business needs.

Desirable Skills and Experience

• Knowledge of IPEC/EXCiPACT and Oracle systems.
• Experience with Lean methodologies and up-to-date knowledge of cGMP and ISO 9001:2015.
• Familiarity with the Pharma Industry and standards for manufacturing compliance.
• Previous experience with FMEA processes and their implementation.

Job-Related Skills & Competencies

• Organizational Skills: Strong organizational abilities with a structured approach to managing workload.
• Team Player: Ability to work effectively within a team and engage with senior management.
• Problem Solving: Skilled in identifying and resolving complex quality issues.
• Communication: Effective communication and influencing skills across all departments.
• Change Management: Ability to drive continuous improvement and act as a catalyst for change.
• Presentation: Competent in delivering presentations to various stakeholders.

This role is ideal for an individual with a strong scientific background, a commitment to quality, and the ability to lead technical projects within a dynamic environment.

£45k - £50k + Benefits