Sterility Assurance Senior Expert

GSK Barnard Castle is a key secondary manufacturing site and has invested heavily in industry 4.0 state of the art, bespoke equipment to support sustained new product introductions and volume increases, and as a key supplier of some of GSK’s blockbuster products, the site contributes revenues of ~$2Bn annually.

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The Sterility Assurance Facility Manager leads sterility assurance projects and has overall oversight of facilities within their areas of responsibility, ensuring compliance with regulatory requirements and industry standards. This role drives contamination control strategies (CCS), ensures the implementation of sterility assurance measures across site facilities, and collaborates with operations to ensure the consistent application of sterility assurance requirements.

• Lead sterility assurance projects to ensure contamination control strategies (CCS) 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.
• Ensure facilities are maintained and operated in alignment with industry best practices, regulatory requirements, and contamination prevention principles.
• 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.
• Act as the primary point of contact for sterility assurance within facilities, representing the team during audits, inspections, and internal reviews.
• Contribute to the harmonisation and continuous improvement of sterility assurance practices across the organisation, sharing knowledge and best practices.
• Develop and deliver training programmes, 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.

• Bachelor's degree in Chemistry, Biochemistry, Microbiology, or a related field
• Significant experience in sterility assurance within the pharmaceutical, biotechnology, or related industry
• Strong knowledge of regulatory requirements around sterility assurance and sterile manufacturing (e.g., FDA, MHRA, EMA) and industry standards (e.g., cGMP, ISO).
• Excellent problem-solving skills and attention to detail.
• Strong leadership and project management abilities.
• Effective communication and interpersonal skills.

• An advanced degree in Chemistry, Biochemistry, Microbiology, or a related field provides advanced knowledge of the scientific principles and methodologies that are crucial for ensuring product quality in the pharmaceutical industry.

• Data Integrity
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Sterility Assurance
• Technical Writing

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