Visual Inspection Subject Matter Expert- Parenteral Products

BioSpace; Indianapolis (IN); On-site; USD 144,000 - 211,200; Full time

Benefits offered by this job

401(k) and pension benefits

Comprehensive medical, dental, and vision insurance

Paid vacation and employee assistance program

Job summary

A global healthcare leader in Indianapolis is seeking a Visual Inspection Subject Matter Expert specializing in parenteral products. Responsibilities include overseeing the visual inspection program, ensuring compliance with regulatory standards, and leading training for quality inspectors. Ideal candidates will have over 10 years of experience in a GMP-regulated environment, with deep knowledge in visual inspection methodologies and standards. This full-time role requires on-site presence with potential domestic and international travel.

Qualifications

• 10+ years of experience in a GMP-regulated environment, specifically with parenteral products.
• In-depth knowledge of visual inspection standards for parenteral products.
• Familiarity with FDA, EMA, and ICH regulatory guidelines.

Responsibilities

• Oversee visual inspection program and processes to ensure quality standards.
• Lead training programs for quality inspectors on GMP requirements.
• Conduct root cause analyses and implement corrective actions.

Skills

GMP compliance

Visual inspection methodologies

Analytical skills

Training and mentoring

Problem-solving

Education

Bachelor's degree in Pharmacy, Chemistry, Engineering, or related field

Tools

Automated inspection systems

Job description

Visual Inspection Subject Matter Expert- Parenteral Products

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Visual Inspection Subject Matter Expert- Parenteral Products

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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.

Job Summary

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, TSMS) 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 and audit-ready.
• 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 (relevant advanced degree preferred).
• 10+ years of experience with parenterals in a GMP-regulated environment, with at least 5+ years of experience in visual inspection for injectable pharmaceutical products.
• 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

• Proven track record of developing 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 is a plus.
• Formal or technical leadership experience.
  
  
  

Additional Information

• This role will require travel (40-50%) both domestic and international.
• This is NOT a remote position and will require on site presence.
  
  
  

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$144,000 - $211,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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