Nitisha Thakur
Principal Quality Assurance Specialist @Cytel
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WORK HISTORY
Principal Quality Assurance Specialist @Cytel
EDUCATION
Baddi University of Emerging Sciences and Technology, Budha (Makhnumajra), Solan
B.pharmacy
National Institute of Pharmaceutical Education and Research
M.pharmacy, Clinical Research
SKILLS
ABOUT NITISHA THAKUR
QMS ISO 9001:2015 Lead auditor~Working in the clinical research industry~Perform internal quality audits to assess compliance with protocol, SOPs, GCP and regulatory requirements and host client/external audits ~Skilled in performing Study audits such as Quality gates.~ Handle quality events, focus on IQA & process improvement and support ~Certified and Skilled in performing Datastudio Dashboards~Skilled in primary and secondary research, illustrating data graphically, translating complex findings into written text reports, and analyze industry trends~Analyze market conditions or trends~ Evaluated quality and integrity of the study by Quality check for site evaluation, site initiation, site monitoring, and site close out visits in clinical operations~Performed administrative activities such as maintaining information files and processing paperwork.Skilled Literature search,Microsoft Excel, Microsoft Word, and Microsoft PowerPoint.~Performed Network meta analysis( safety,efficacy) and cost-effectiveness study ~Strong business development professional with a Master\'s degree focused in clinical research from National Institute of Pharmaceutical Education and Research.
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