Looking for a qualified investigator, to provide guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all investigations, corrective and preventive actions (CAPA}. The investigator will work with the operations leadership team and Quality Assurance to facilitate the consistent and disciplined execution of the investigation system ensuring the completeness and comprehension of the investigations while determining the most probable root cause. The investigator will review and analyze CAPA effectiveness through appropriate tracking and trending methods in order to prevent reoccurrence. Investigator is also in charge of daily/weekly reports to management.
Scope; Activities, Tasks:
· Investigator will perform the following activities:
· Investigate, write and close out root cause investigations/CAPAs.
· Implement necessary follow-up verification checks 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 the quality investigational system and assist with improvement/revisions
· Attend any investigational related meetings.
Knowledge of the following areas are critical:
· Manufacturing Packaging and Inspection – Investigations experience
· GMP Pharma experience
· Experience performing investigations in a Pharma environment
· Experience writing CAPAs in a Pharma environment
· Some knowledge of aseptic processing
· Demonstrated problem-solving skills
Helpful experience:
· Quality Investigations and a FDA remediation/Combination Products pharmaceutical manufacturing environment
· Ability to demonstrate analytical thinking skills
· Root Cause Analysis performed in an aseptic environment
· Investigations performed in an aseptic environment
· cGMP's both US and other countries
· Manufacturing Environment, Processes and Intradepartmental Linkages
· Additional biology or microbiology experience
· FDA Compliance and GMP experience