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Manager, QA Validation
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Full-time
- Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research-based pharmaceutical company.
- The Manager, QA Validation is responsible for providing leadership and strategic direction to the establishment of the validation/qualification programs (including the Qualification/PM/Calibration of instruments, equipment, and facilities) ensuring alignment with corporate standards and regulatory guidance.
- Act as the quality / validation SME for Change Controls supporting GMP/GLP systems.
- Provide hands-on review and subject matter expertise of Validation lifecycle documentation including Process Design Documents, Process Control Strategy, Master Plans, Protocols and Reports
- Apply risk based methodologies in the oversight of validation efforts and CSV activities
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