The investigators will work with the Lab. leadership team and Quality Assurance to facilitate the consistent and disciplined execution of the investigation ensuring the completeness and comprehension of the investigations while determining the most probable root cause and CAPA when applicable.
Scope; Activities, Tasks:
Investigators will perform the following activities:
• Investigate, write and close out root cause investigations/CAPAs.
• Provide updates on a daily basis (progress) on investigation Corrective and Preventive Action (CAPA} items
• Coach Company colleagues to facilitate a focused knowledge transfer regarding quality investigations
• Review Company's SOPs related to given investigation and assist with improvement/revisions
• Attend any investigational related meetings.
Knowledge of the following areas are critical:
• Lab Investigations experience
• GLP Pharma experience
• Experience performing investigations in a Pharma environment solid dosages
• Experience writing CAPAs in a Pharma environment
• Demonstrated problem solving skills