Eli Lilly and Company
Senior Director - Technical Services Visual Inspection Steward
Eli Lilly and Company, Durham, North Carolina, United States, 27703
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $142,500 - $253,000.
Job Summary :
Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck. We are seeking a highly skilled and detail-oriented Visual Inspection Subject Matter Expert (SME) specializing in parenteral pharmaceutical products. The SME will be responsible for overseeing and enhancing our visual inspection program and processes to ensure the highest quality standards. The ideal candidate will provide expert guidance on inspection methodologies, lead training programs, optimize systems, lead harmonization of visual inspection control strategies across the internal and external manufacturing network, and drive compliance with regulatory requirements. This role requires in-depth technical knowledge, strong analytical skills, and a commitment to product quality and patient safety. Key Responsibilities : Visual Inspection Program Development : Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices. Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes. Establish risk-based inspection strategies for different types of parenteral products and materials (e.g., vials, syringes). Harmonize visual inspection control strategies and practices across the internal and external manufacturing network. Technical Expertise & Process Optimization : Serve as the go-to expert on visual inspection processes, equipment, and quality standards for the parenteral product lines. Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality-related events. Collaborate with cross-functional teams (QA, manufacturing, engineering) to identify and implement process improvements that enhance efficiency and reduce inspection errors. Training & Development : Develop and deliver training programs for quality inspectors, operators, and other relevant staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements. Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization. Compliance & Documentation : Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection processes and documentation up-to-date. Participate in internal and external audits, providing expert insights and support for any inspection-related findings. Act as subject matter expert for the development and maintenance of internal quality system documents (Global Q standards, Common Q practices,…) and execution documents (validation reports, PoDs…) to support the visual inspection Quality System. Innovation & Continuous Improvement : Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency. Identify opportunities for process automation, working closely with engineering teams to implement new tools and technologies. Basic Qualifications : Bachelor’s degree in Pharmacy, Chemistry, Engineering, or a related field (advanced degree is preferred). 10+ years of experience in visual inspection for injectable pharmaceutical products in a GMP-regulated environment. In-depth knowledge of visual inspection standards, practices, and equipment specific to parenteral products. Familiarity with regulatory guidelines (FDA, EMA, ICH) and experience with regulatory inspections. Additional Preferences : Demonstrated development of training programs and mentoring inspection teams. Strong analytical and problem-solving skills, with attention to detail and a commitment to quality. Experience with automated inspection systems and/or artificial intelligence for quality control. Additional Information : There will be some travel (25%) both domestic and international required for this role. This is NOT a remote position and requires an onsite presence.
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Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck. We are seeking a highly skilled and detail-oriented Visual Inspection Subject Matter Expert (SME) specializing in parenteral pharmaceutical products. The SME will be responsible for overseeing and enhancing our visual inspection program and processes to ensure the highest quality standards. The ideal candidate will provide expert guidance on inspection methodologies, lead training programs, optimize systems, lead harmonization of visual inspection control strategies across the internal and external manufacturing network, and drive compliance with regulatory requirements. This role requires in-depth technical knowledge, strong analytical skills, and a commitment to product quality and patient safety. Key Responsibilities : Visual Inspection Program Development : Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices. Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes. Establish risk-based inspection strategies for different types of parenteral products and materials (e.g., vials, syringes). Harmonize visual inspection control strategies and practices across the internal and external manufacturing network. Technical Expertise & Process Optimization : Serve as the go-to expert on visual inspection processes, equipment, and quality standards for the parenteral product lines. Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality-related events. Collaborate with cross-functional teams (QA, manufacturing, engineering) to identify and implement process improvements that enhance efficiency and reduce inspection errors. Training & Development : Develop and deliver training programs for quality inspectors, operators, and other relevant staff, focusing on the visual inspection of parenteral products and adherence to GMP requirements. Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization. Compliance & Documentation : Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection processes and documentation up-to-date. Participate in internal and external audits, providing expert insights and support for any inspection-related findings. Act as subject matter expert for the development and maintenance of internal quality system documents (Global Q standards, Common Q practices,…) and execution documents (validation reports, PoDs…) to support the visual inspection Quality System. Innovation & Continuous Improvement : Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency. Identify opportunities for process automation, working closely with engineering teams to implement new tools and technologies. Basic Qualifications : Bachelor’s degree in Pharmacy, Chemistry, Engineering, or a related field (advanced degree is preferred). 10+ years of experience in visual inspection for injectable pharmaceutical products in a GMP-regulated environment. In-depth knowledge of visual inspection standards, practices, and equipment specific to parenteral products. Familiarity with regulatory guidelines (FDA, EMA, ICH) and experience with regulatory inspections. Additional Preferences : Demonstrated development of training programs and mentoring inspection teams. Strong analytical and problem-solving skills, with attention to detail and a commitment to quality. Experience with automated inspection systems and/or artificial intelligence for quality control. Additional Information : There will be some travel (25%) both domestic and international required for this role. This is NOT a remote position and requires an onsite presence.
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