Job Description
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 -
- 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
- Good co-ordination skills with another department.
- Good knowledge about current trends of Data integrity.
- 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.
