Quality Assurance Manager - Pharmaceuticals / life sciences
GMP / New Drug Development / Sterile Medicinal products
Salary: £100,000k +
Type Full time permanent
Location: Darlington - Tee Valley - Teesside
Relocation package available
Sector: Global Pharmaceuticals manufacturing / supply chain
This is an excellent opportunity to join a global pharmaceuticals organisation in a new Quality Assurance Expert lead appointment. You will be responsible for Sterility Assurance across the GMP site, projects, new drug development areas and have overall sterile responsibility, ensuring compliance with regulatory requirements and global industry standards.
Key Experience
* Annex 1 GMP - manufacturing of sterile medicinal products
* Lead sterility quality assurance expert
* GMP Pharmaceuticals
* Drive contamination control strategies
* Provide strategic oversight
* Process improvements / quality / risk management
* Pharmaceuticals / life sciences Quality Assurance
Key Responsibilities
* Lead sterility assurance projects to ensure contamination control strategies are effectively implemented and aligned with site objectives and regulatory requirements.
* Provide overall oversight of facility operations, ensuring compliance with sterility assurance standards and contamination control measures.
* Drive the implementation of sterility assurance programmes across facilities, collaborating with cross-functional teams site and above site teams to ensure consistency and effectiveness.
* Collaborate with operations and quality teams to ensure contamination control measures are integrated effectively into manufacturing processes.
* Monitor performance metrics related to facility operations and contamination control, identifying areas for improvement and implementing corrective actions as needed.
* Sharing knowledge and best practices globally
* Develop and deliver training programs, ensuring staff understand and consistently apply sterility assurance and contamination control measures.
* Support the strategic planning and execution of facility upgrades or projects to optimise contamination control systems and ensure regulatory compliance.
* Sponsorship of Investigations and Root Cause Analysis: Sponsor investigations and root cause analysis for deviations, providing strategic leadership and overseeing corrective and preventive actions.
* Culture Leadership: Champion a culture of continuous improvement, innovation, and excellence, promoting a positive and inclusive work environment.
Qualifications & Skills
* Degree in Science, Engineering or related field.
* Bachelor's degree in Chemistry, Biochemistry, Microbiology, or a related field Advanced certifications
* Proficiency in sustainability software and data analysis tools.
* Strong communication, project management, and client engagement skills.
Benefits
* Leading salary and benefits package
* Opportunities for professional development and extra certifications
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