The Sr. QA Specialist reports to the Director of QA and is responsible for activities related to the investigations/deviations/CAPA / OOS/ process:
- Co-ordinate with and provide guidance to Cross-functional Investigation team members on complex technical investigations
- Review and at times write, deviations related to manufacturing, packaging, warehouse, facility, and engineering, etc.
- Execute activities in support of Drug Product Complaint Investigations
- Define quantitative and qualitative data requirements for a robust investigation from various areas of operation for analysis (i.e., manufacturing floor, packaging floor, warehouse, etc.)
- Review investigation reports and supportive documentation (including data) for accuracy and completeness, where needed.
- Review, monitor, and Track all Deviations, CAPA'S throughout the company. Lead a weekly Deviation and CAPA meeting to assure all deviations, CAPA'S are promptly closed