Parenteral Visual Inspection Expert — Quality & Compliance Lead

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

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.