Hr Recruiter at Spigot Software
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Senior Specialist - Quality Assurance (3-15 yrs)
Key Duties & Responsibilities:
- Review of batch records, Certificates of Analysis (CofA) and other Quality related documentation
- Create and revise quality assurance policies and procedures.
- Work collaboratively with other departments to conduct deviation investigations and write reports.
- Provide QA review of excursion/non-conformances, deviations, OOT, OOS, and CAPA Reports.
- Track and trend Key Performance Quality Indicators (KPQIs)
- Review and approve method transfer, specifications, validation protocols, and summary reports.
- Review and approve supplier, service provider, and subcontractor surveys.
- Assist in customer audits, regulatory inspections and conduct internal audits.
- Participate in preparation of response to client audit and regulatory inspection.
- Serve as Quality representative on assigned client projects.
- Understand and apply ICH, USP, FDA, EU and ISO standards and guidance effectively.
- Train and provide mentorship to co-workers as needed
