Executive, Indore

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 conclusionsSupport 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 actionsData 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.