Job Summary:
Provide support for root cause analysis and investigation closure, product quality complaints, and overseeing overall site compliance.
Responsibilities:
- Support multiple departments with documentation, root cause analysis, and Stage II OOS/OOT investigations
- Provide resolutions for product quality complaints and product inquiries
- Perform statistical analysis and manage QMS Trackwise
- Prepare annual product quality review reports for commercial products
Experience:
- 6-8 years of experience in a compliance/complaint handling QA role within the Pharmaceutical industry
- Strong experience with APQR and product quality complaints
- Experience using QMS like Veeva, Trackwise, SAP, etc
- Experience in commercial stage GMP environment
