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
- 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
- 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
