CJ & L Consultancy Ltd
CJ & L Consultancy Ltd guides medical and biotech companies. We help them with the certification of their Quality Management Systems (QMS). Our team has extensive experience in the field, ensuring compliance with industry standards while streamlining the certification process.
I am a seasoned professional in Operations, Quality, and Continuous Improvement. I have over 20 years of experience across various industries. These industries include technology, healthcare, aerospace, manufacturing, packaging, and pharmaceuticals. I have a strong track record in managing business operations. I lead large teams to meet targets and key performance indicators (KPIs). I excel in designing quality management systems. I implement these systems in compliance with ISO13485, ISO27001, PS9000 and ISO14001. I also track regulatory requirements of MDD, MDR, GCP, GLP, GMP and ICH. I offer guidance to stakeholders on corrective measures and make sure compliance with evolving standards and regulations. I work collaboratively with C-Suite executives and develop strategies that align with key commercial goals and objectives. Notable projects I have led include implementing a project management system. Another is an Electronic Quality Management System. Both projects enhanced process and cost efficiencies. Whilst achieving ISO13485 certification for a startup company.
Key Skills:
Strategy: A highly motivated operations leader is ready to challenge the status quo. They take responsibility for leading initiatives to improve efficiencies. They implement systems, reduce costs, and always keep legislative compliance.
Operational Management & CI: Accustomed to working in fast paced environments. Skilled in cutting through complexities and supplying clarity and direction. Capable of coordinating multi-disciplinary teams across a spectrum of areas. I am a champion of change and transformation. I conduct reviews of functions or departments across organizations. I re-engineer resources, processes, and systems to improve productivity levels. I have knowledge of Lean Six Sigma, 5S, 8D, and 5 Why practices.
Quality: Partner with start-ups and medium to large companies. Create detailed project plans for a Quality Management System. Implement this system according to the requirements of ISO13485, 27001, PS9000, and 14001. Make sure it aligns with all associated regulatory requirements of MDD, MDR, GCP, GLP, GMP, and ICH. Co-host Stage 1 and Stage 2 audits for certification or Notified Body. Offer an extra service to finish internal audits within agreed timelines.
People Leadership: Motivate and empower high calibre people. Set challenging KPIs. Support teams to put in place lasting legacies of process and organisational improvement and growth.
Project Management: Leading projects through full lifecycles. These lifecycles follow industry standards and best practices to meet objectives. Objectives include software/application deployments, regulatory compliance, and process improvement initiatives.
Stakeholder Engagement: Engage effectively with stakeholders up to C-Suite or Board level. Gain buy-in and approval for initiatives and projects.
Products and services
Information Security Management System (ISMS)
- Offering comprehensive support and guidance in achieving ISO27001 certification with your selected certification or notified body.
Additionally, we offer assistance in conducting internal audits and delivering gap analysis or opportunities for improvement.
Business Improvement Support
- Gap assessments
- Simulated inspections
- Staff training and development
- Support before and after inspections
- Process improvement initiatives
- Technical Good Manufacturing Practices Quality Assurance assistance – intricate investigations, technology transfers
Regulatory Compliance Guidance
- Determining the classification of devices and the relevant regulatory requirements.
- Creating a regulatory strategy to launch the product in the selected country or countries and region or regions.
- Preparing for and facilitating inspections by Regulatory Authorities, while also managing remediation efforts.
Quality Management System
- Projects focused on the design, implementation, and improvement of Quality Management Systems (QMS)
- Services for writing and reviewing policies and Standard Operating Procedures (SOPs)
- Drafting and reviewing technical agreements
Extra Services
- Development of audit schedules based on risk assessment
- Senior temporary support in Quality/Technical Operations
- Management of vendor performance
- Execution of unbiased ‘internal’ audits
