Executive

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 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.