Deviation Investigations Specialist

• The Deviation Investigations Specialist will lead and support cGMP investigations for oral solid dosage manufacturing and complex pharmaceutical operations.
• The role involves root cause analysis, CAPA management, product impact assessments, data analysis, cross-functional collaboration, and ensuring compliance with pharmaceutical quality systems and regulatory standards.

Requirement/Must Have:

• Master s or Ph.D. degree in a scientific or engineering discipline with relevant pharmaceutical industry experience.
• Experience supporting investigations within pharmaceutical manufacturing, engineering, or QC laboratory environments.
• Strong knowledge of cGMP regulations, pharmaceutical quality systems, and data integrity requirements.
• Strong technical writing and documentation skills.
• Experience performing root cause investigations using structured methodologies.
• Ability to analyze manufacturing, engineering, and laboratory data.
• Strong cross-functional communication and facilitation skills.

Experience:

• Experience leading or co-authoring deviations, nonconformances, atypical event investigations, OOS, or OOT investigations.
• Experience working in oral solid dosage (OSD) manufacturing environments preferred.
• Experience with CAPA development, implementation, and effectiveness monitoring.
• Experience using electronic quality systems, MES, LIMS, historian tools, and trending systems preferred.
• Experience supporting audit and inspection readiness activities.
• Experience coordinating with Operations, Engineering, QC, and QA teams.

Responsibilities:

• Lead and support cGMP investigations for manufacturing and complex operational events.
• Coordinate event triage, containment activities, escalation, and immediate actions.
• Collect, organize, and analyze manufacturing, laboratory, and engineering evidence.
• Perform structured root cause analysis using tools such as 5-Why, fishbone, and fault tree analysis.
• Document compliant investigation conclusions and product impact assessments.
• Define, track, and monitor CAPAs and effectiveness checks.
• Support implementation of corrective and preventive actions on the manufacturing floor.
• Prepare detailed investigation and CAPA documentation following Good Documentation Practices.
• Support trending analysis and continuous improvement initiatives.
• Participate in audit and inspection readiness activities including preparation of evidence packages and responses.
• Collaborate with cross-functional teams to support quality and compliance objectives.

Should Have:

• Experience with electronic quality management systems and manufacturing data systems.
• Knowledge of blending, granulation, compression, coating, encapsulation, and supporting utility systems.
• Experience with data trending and risk-based decision making.
• Ability to manage multiple investigations simultaneously.

Skills:

• cGMP investigations and deviation management.
• CAPA management and effectiveness checks.
• Root cause analysis and problem-solving.
• Pharmaceutical quality systems and compliance.
• Technical writing and documentation.
• MES, LIMS, eQMS, and historian systems.
• Data analysis and trending.
• Cross-functional collaboration and communication.
• Risk assessment and product impact evaluation.

Qualification And Education:

• Master s or Ph.D. degree in a scientific or engineering discipline required.
• Relevant pharmaceutical manufacturing or QC investigation experience required.