Savitha Ashwin
Site Lead at Nne
Based in Hillerød, Denmark
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Seniority
Manager
Department
General Business & Management
Location
Hillerød
Industry
Engineering Services
Company size
3.4K
Contact information
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s•••••••@nne.com
Phone
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Background
About Savitha Ashwin
With nearly 17 years of hands-on experience in the manufacturing, validation, commissioning, and qualification of equipment, facilities, and systems, I have contributed to numerous Green field & Brown Field GMP projects within the Pharmaceutical and Biopharmaceutical sectors. Currently, I serve as the Site Lead for CQV Project Management, a greenfield API mAbs facility in Denmark at the NN site. My key responsibilities include developing CQV validation strategies, people management,conducting training, and managing CQV activities while ensuring compliance with GEP and GMP standards Key Skills & Expertise: Strategic Planning & Validation Activities Commissioning, Qualification & Verification (CQV) Protocols/Test Plans & Reports. Client Relationship Management & Quality Assurance CTOP, ETOP & QTOP Document review Team Leadership & Training Development Regulatory Knowledge: ISPE, ASME, ASTM, EU GMP, 21 CFR 11, GLP, GAMP5, GEP Quality Management Systems (QMS): Deviation handling, CAPA, risk assessment & mitigation, and change controls Risk-based Validation & Lean Qualification: Expertise in ASTM E2500 approach Certified Lean Six Sigma Green Belt Level (LSSGB)
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