Develop the Investigation Plan and present the Investigation Plan and results at stage-gate review. (High CA only).
Determine the Define/Measure/Analyze elements of the investigation.
Determine scope of the investigation. Assume ownership and lead the Investigation phase of a CAPA.
Identify appropriate/cross-functional team members and assemble the Investigation Team.
Confirm corrections/containment identified based on the investigation results.
Identify and employ appropriate investigation tools.
Determine the appropriate data sources to be evaluated for the investigation, and obtain the required data
Investigate the root cause(s) of the issue.
Clearly document the investigation results.
Communicate the investigation results to Ensure investigation follows the CAPA procedure, including all data entry requirements per the checklists.
Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle.
Collaborate with Action Owner/CAPA Owner to develop the Action Plan/Effectiveness Plan.
Document Action Plan.
Document Effectiveness Plan, including acceptance criteria and timeframe/number of opportunities.
Requirements:.
Understand strategies and be able to invent new methods or new avenues of investigation.
Thorough knowledge of applicable CAPA procedures, specifications, regulations and standards.
Strong analytical and problem-solving skills.
Good communication and leadership skills.
Good interpersonal/communication/influencing/negotiation skills.
Good project management skills.
Working knowledge of FDA regulations and application of Good Manufacturing Practices. Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily.
Bachelor's degree (in science or engineering preferred) or equivalent experience.
2+ years of experience in Quality, Manufacturing, Engineering or related field
Seniority level
Entry level
Employment type
Contract
Job function
Other, Information Technology, and Management
Industries
Pharmaceutical Manufacturing
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