- The Lead Investigator researches, expedites, solves, and tracks manufacturing discrepancies and resulting commitments within their respective PPU or assignment
- The Lead Investigator initiates Manufacturing Investigation Reports (MIR) and coordinates the actions required for its resolution
- The position works closely with Operations and Quality Assurance, ensuring that all investigations are performed according to corporate and site guidelines
- Ensures that MIRs accurately identify all processing and manufacturing deficiencies to determine and classify root cause
- Gathers, coordinates, and reviews validation & batch documentation, standard operating procedures, testing and manufacturing specifications, testing results, training & calibration records, regulatory & Level I and II policies Sets realistic objectives and clearly assigns accountability for tasks and decisions
- Writes clear concise summaries of investigations, product impact assessments, and commitments
- Provides solutions for potential and identified problems
- Track, trend, and evaluate manufacturing discrepancies and work to eliminate root causes
- Good Manufacturing Practices (GMP) Compliance Training Desired 1-3 Years
- 21 CFR Part 11 Regulatory Knowledge Desired 1-3 Years
- Manufacturing Industry Skills Desired 1-3 Years
- BS 3–5 years of Pharmaceutical Manufacturing, 2 years in Laboratory, manufacturing or Quality Assurance environment
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