Job Description
Looking for a Lead Investigator that manages deviation investigations for manufacturing, ensures compliance with GMP/FDA regulations, and oversees corrective actions.
Lead Investigator will be responsible for the following deliverables:
• Ensure that all QE’s, NTR’s, NOE’s and CAPA’s are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence.
• Reviews and provides input to regulatory submissions applicable to area of responsibility.
• Leads QE’s and CAPA’s trend evaluation.
• Participates in the new product introduction process to determine requirements for documentation, materials, training and equipment modifications.
• Supports establishment of process monitoring parameters and control limits.
• Supports the assessment of deviations and process monitoring data
• Monitors and evaluates parameters in existing (on-going) processes to ...
Lead Investigator will be responsible for the following deliverables:
• Ensure that all QE’s, NTR’s, NOE’s and CAPA’s are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence.
• Reviews and provides input to regulatory submissions applicable to area of responsibility.
• Leads QE’s and CAPA’s trend evaluation.
• Participates in the new product introduction process to determine requirements for documentation, materials, training and equipment modifications.
• Supports establishment of process monitoring parameters and control limits.
• Supports the assessment of deviations and process monitoring data
• Monitors and evaluates parameters in existing (on-going) processes to ...