PurposeManufacturing and engineering investigator: Responsible for QA oversight, review, and approval of manufacturing and engineering investigations, including deviations, breakdowns, utility failures, and atypical events. Ensures investigations are scientifically justified, compliant, and supported with robust CAPA and risk assessment, minimizing recurrence and ensuring product quality..

Position / Job TitleExecutive

DepartmentQuality Assurance – Investigator

Reporting ToSenior Manager- Quality Assurance

LocationPithampur

Years of Experience 5-8 Years

Dosage Form-Solid Oral

Job Responsibilities / Deliverables

Investigation Review & QA Oversight
Review and approve:
Manufacturing deviations (granulation, compression, coating, packing)
Engineering incidents (equipment breakdown, utility failure, HVAC issues)
Atypical events and process interruptions
Ensure investigations comply with cGMP and regulatory expectations (US FDA/MHRA)
Challenge weak or unsupported root causes (e.g., generic “operator error”).
Scientific Evaluation & Decision Making
Critically evaluate:




Batch Manufacturing/Packaging Records (BMR/BPR)
In-process controls and yield data
Equipment logs and breakdown history
Environmental monitoring (where applicable)

Ensure

Logical hypothesis and structured investigation
Scientifically justified conclusions
Support product impact assessment and batch disposition decisions
Root Cause Analysis (RCA) Oversight
Ensure use of structured RCA tools:
5-Why
Fishbone (Ishikawa diagram)
Fault Tree Analysis (where required)
Confirm identification of true root cause (process, equipment, method, material, or human factor)
Ensure transparent linkage between root cause and CAPA
CAPA Review & Effectiveness
Review and approve Corrective and Preventive Actions (CAPA)
Ensure CAPAs are:
Risk-based and practical
Aligned with root cause
Track CAPA implementation and ensure effectiveness checks are performed
Prevent recurrence of similar deviations
Engineering & Equipment Investi

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📍 Indore