What are the responsibilities and job description for the Quality Assurance and Validation Lead position at cyberThink Inc?
About the Role
CyberThink Inc is seeking a highly skilled Senior Quality and Validation Manager to support manufacturing excellence in industrial processes.
The successful candidate will lead the development and implementation of robust processes, testing strategies, and associated know-how transfer to ensure accuracy, conformity, and competitiveness of vaccine and biologic production.
- Develop and execute process validation plans, reports, and procedures to support adjuvant manufacturing activities.
- Spearhead the execution of development and validation related studies.
- Document and interpret study results with recommendations to stakeholders.
- Provide technical leadership as a subject matter expert in multiple areas of responsibility.
- Develop and execute training programs for appropriate audiences.
- Ensure compliance with cGMP, internal, and external quality and regulatory guidance, and health and safety guidelines.
- Leverage project team leadership skills within area of expertise.
- Assess existing processes and workflows to identify opportunities for improvement.
- Translate processes to commercial operations effectively.
- Own equipment unit operations and technology capabilities.
- Communicate findings and proposals to upper management.
- Enhance Manufacturing Technology strategic programs by addressing non-conformance issues related to change controls, deviations, CAPAs.
- Participate in Gemba/shop floor walk-throughs to learn about production processes and/or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents.
- Develop and update standard operating procedures and related technical documents to align with program strategies under a cGMP environment.
