Providing preparative isolation support across the verticals.Pocessing sound theoritical and practical knowledge on various impurity isolation techniquesAble to handle different preparative LC, Flash LC and respective softwares.Planning preparative analysis to meet the delivery timelinesTo scale up the methods to prep scale to support R&D lab.Pocessing sound preparative method development knowledge and skills.Pocessing sound preparative purification knowledge of peptides.Performing & reviewing analytical dataPreparation of Instrument calibration schedule and ensure compliance to the schedule.Capable in Incident investigation procedures & Management of change procedures such as raising Change control & Incidents and ensuring on time closure of assigned CAPA's.Preparation & regular review of SOP related activities and ensuring current practices are as per existing SOP.Maintaining good documentation practice, data integrity, safety & GLP normsTo reach understanding of the application of new technology.To ensure complete compliance & quality.Well aware of cGMP, cGLP and other regulatory guidelines such as ICH etc.Key Personal Attributes :
- Self-starter, able to work independently with minimal Supervision.
- Good communication and writing skills.
- Learning ability
Band : Violet 4
Educational Qualification : Msc / M.Pharm
Experience : 4-7 years
Qualifications
Educational Qualification : Msc / M.Pharm
Skills Required
Method Development, Incident Investigation