Job Description

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 explicit 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
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