• Designing data acquisition trials
• Assessing results & analyzing trends
• Applying statistical methodology to complex data
• Using statistics to make forecasts of the product shelf life
• Presenting information in a variety of formats, conveying complex information to people who may not be specialists
• Liaising with colleagues & attending global meetings
• Design research projects that apply valid scientific techniques and utilize information obtained from baselines or historical data in order to structure uncompromised and efficient analyses.
• Develop and test experimental designs, sampling techniques, and analytical methods
• Exposure to the stability analysis and instrumentation like LC, Disso.
• Knowledge of Regulatory guidelines on stability like ICH guidelines.
• Planning of analytical projects and ensure deliverables
• Leading a group of people
• Handling of Quality records in GMP Lab
• Must be able to draw interpretation out of the stability data and trending
• Experience in writing protocol, reports. Reviewing the data of the reports.
• Experience of working in a regulated environment is preferred.
• Manage communication with Global partners such as project leaders, analytical teams and other statisticians People management, training
• M.SC or M. Pharm or Ph.D. or equivalent
• At least 12 years in reputed company. Exposure on GMP Systems, Statistical Tools.
Qualification : M.Pharm / Ph.D or equivalent
Location : Maharashtra-Greater Mumbai
Industry Type: Pharma / Healthcare / Clinical research
Functional Area: R&D
Job ID: 1805693655W
Last Date: 25th December, 2018
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