:

Manufacturing 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 Title - Executive

Department - Quality Assurance - Investigator

Reporting To - Senior Manager- Quality Assurance

Location - Pithampur

Years of Experience - 5-8 Years

Dosage Form - Solid Oral

Job Responsibilities / Deliverables -

1) 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 clear 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 Investigation Oversight

Review investigations related to

Equipment failures and breakdowns

Utility systems (HVAC, compressed air, purified water, etc.)

Ensure linkage between

Breakdown and product impact

Preventive maintenance (PM) gaps and deviation

Verify adequacy of engineering corrective actions

- Data Integrity & Compliance

Ensure adherence to ALCOA+ principles

Review

Equipment usage logs

Electronic records and audit trails (if applicable)

Identify and escalate data integrity risks

Ensure no backdated entries or undocumented activities

- Trending & Risk Management

Review and monitor trends for:

Manufacturing deviations

Equipment breakdowns

Identify recurring issues and systemic gaps

Support APQR/PQR and quality metrics review

- Audit & Inspection Readiness

Act as QA representative during:

Internal audits

Regulatory inspections (US FDA, MHRA, WHO)

Defend investigation quality with scientific rationale

Ensure minimal audit observations related to investigations

9)Good co-ordination skills with another department.

10)Valuable knowledge about current trends of Data integrity.

11)Good knowledge about current Regulatory Guidance and requirement

Qualifications & Pre-Requisites

Must-Have Skills: B Pharmacy/ M. Pharmacy

Must have knowledge on handling manufacturing and engineering investigations.

Good analytical and problem-solving skills

Exposure to various regulatory bodies like US FDA, MHRA, TGA.

Exposure to specific dosage forms like OSD.

Ability to work in cross-functional teams with team coordination and work distribution.

Good communication skill which results to coordination with functions like Manufacturing, Engineering, Warehouse, QC and Regulatory.

📌 Executive (Indore)
🏢 Rubicon Research
📍 Indore