Job Title SynonymsJob DescriptionJob Title: Quality Engineer – Pharmaceutical IndustryOverviewA Quality Engineer (QE) in the pharmaceutical industry ensures that products, processes, and systems comply with regulatory, safety, and quality standards throughout the product lifecycle. This role focuses on Good Manufacturing Practices (GMP), process validation, risk management, and continuous improvement to maintain product quality and patient safety.Key ResponsibilitiesQuality Systems & ComplianceSupport and maintain compliance with FDA regulations (21 CFR Parts 210, 211, 820), EU GMP, and ICH Q10 standards.Implement and improve Quality Management System (QMS) processes such as deviations, CAPA, change control, and document management.Participate in internal, external, and regulatory audits and inspections, ensuring audit readiness at all times.Ensure manufacturing, packaging, and laboratory operations adhere to GMP, GLP, and GDP principles.Process Validation & QualificationDevelop and execute process validation, equipment qualification (IQ/OQ/PQ), and cleaning validation protocols and reports.Review and approve validation documentation to ensure compliance with regulatory standards.Partner with Manufacturing and Engineering to ensure validated state is maintained throughout equipment and process changes.Nonconformance, Deviation & CAPA ManagementLead or support investigations for nonconformances, deviations, and complaints using tools like 5 Whys, Fishbone, and Root Cause Analysis.Implement Corrective and Preventive Actions (CAPA) and verify their effectiveness.Support continuous improvement activities to reduce recurring quality issues.Quality Risk Management & Continuous ImprovementApply risk-based approaches (FMEA, HACCP, Risk Matrix) to identify and mitigate quality and compliance risks.Drive process improvement initiatives using Lean or Six Sigma methodologies to enhance yield, reduce variability, and improve quality performance.Monitor key quality metrics (OOS, deviations, complaints, CAPA closure) and develop trend analysis reports.Supplier & Material QualitySupport supplier qualification, audits, and material quality assessments in collaboration with Procurement and Supplier Quality teams.Review and approve supplier documentation and Certificates of Analysis (CoA).Participate in supplier risk management and performance improvement activities.Documentation & TrainingAuthor and review SOPs, validation protocols, batch records, and quality reports.Provide GMP and quality system training to manufacturing and laboratory personnel.Ensure documentation accuracy and data integrity in compliance with ALCOA+ principles.Required Skills & CompetenciesStrong understanding of GMP, GLP, GDP, and Quality by Design (QbD) principles.Familiar with FDA, EMA, and ICH quality guidelines and inspection practices.Knowledge of validation, risk management, and root cause analysis tools.Proficiency in data analysis, statistical process control (SPC), and quality management software (TrackWise, Veeva, MasterControl).Strong technical writing, communication, and problem-solving skills.Attention to detail and ability to work in a highly regulated environment.Education & ExperienceBachelor’s Degree in Pharmacy, Chemical, Biomedical, Industrial, or Quality Engineering (or related life sciences field).3–7 years of experience in pharmaceutical manufacturing, quality assurance, or validation.Preferred Certifications:ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)Lean Six Sigma Green Belt / Black BeltGMP or Validation Certification (e.g., PDA, ISPE)