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Ankleshwar GJ IN Zentiva Full time

Position Title Executive Manufacturing Science and Technology MST Qualification and Experience POST GRADUATE IN CHEMISTRY PHARMACY Experience 0-7 years of Experience as an analyst Development technologist in the Pharmaceuticals API industry GMP GLP knowledge Job overview Providing analytical support for Chemistry activities ensuring compliance to regulatory group directives quality requirements safety standards to fulfill the organization s objective living Group s Values and Code of Ethics Responsibilities Analytical method validation Analytical method Development Analytical method transfer Analytical method validation CMC activity Sampling testing of Process water Raw materials Intermediates APIs stability samples hold time study samples Cleaning validation samples Sending samples to third party customer Preparation and approval of CoA Generation and archival of GMP documents Preparation of system operational SOPs using eDMS Maintaining inventory of laboratory reagents and chemicals Providing analytical support to pilot plant in case of deviation investigation Co-ordination with pilot plant PRD to provide analytical support Investigation in case of OOS OOT laboratory incidence deviation customer complaint Impurity reference standard qualification Management of change control OOS OOT deviation cGMP Compliance to current GMP guidelines Follow ALCOA principal maintaining GMP data Compliance to local and international norms Quality HSE Knowledge of change control and deviation management Regulatory compliance Regular Pharmacopoeia and regulatory requirement review Training of self on quality and HSE systems Instrumentation Operation calibration of HPLC GC HSGC UPLC UV FITR DSC other laboratory instruments Trouble shooting for said instrument Co-ordination with service provider for repairing and preventive maintenance Qualification of laboratory instruments Management of logbooks Other Complying to HSE Requirements Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations Carrying out any other assignments or projects as per the instruction of the Dept Head to meet with the organizational objectives and priorities RequirementsGMP GLP knowledge Good coordination communication skills Analytical ability Knowledge on LIMS QMS What makes this position unique This position will provide good exposure to work in Analytical Method Development and validation GMP GLP environment Location Information Ankleshwar Gujarat India

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