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 optimize process times/productivity, equipment performance, yields and quality.
• Provides technical assistance to identify, recommend and implement process and equipment modifications to improve process performance; to identify and assist in the implementation of cost reduction projects and assuring the manufacturing area is in cGMP's compliance.
• Write, evaluate and revise the required manufacturing documentation (i.e. SOP's, MBR's, etc.) and may assist in providing training on scientific or technical aspects of the processes.
• Assists with generation and execution of validation protocols and reports.
• Participate in regulatory inspection when necessary.
• Assists the area managers and supervisory personnel to solve any production technical problem (i.e. Process / equipment troubleshooting, yield, cycle time, quality and productivity).
• Provides alternatives and recommendations to improve and maximize processes and equipment.
• Participates in Environmental Regulatory and Compliance Permits and Process Safety Hazards evaluation.
• Promote and model the Client Core Behaviors, facilitating teamwork.
• Supports all site Initiatives and any other assignments based on business needs.
