* Chromatography Column techniques* Bioprocess Manufacturing* Aseptic Techniques* Filtration Techniques*

* Handled a plant capacity of 50 -75 MT of API per Month. * Production and raw material planning as per requirement.* Process improvements, cost reduction and optimal utilization of process equipment’s.* Fulfill the requirements of internal and external customers.* Capex, Opex and manpower Planning.* Handled internal, external audits and compliance for the same.* Monitor, review and approve the cGMP related documents in timeline.* Prepared the off line reports and support the cross functional department to ensure the improvement of the system.* ERP (Microsoft Dynamics & Oracle e-business suite) Updating.* Ensure all the production activities meet the statutory and regulatory requirements.

* Involved in process suitability study in optimization phase of new product development in collaboration with R&D to stream line the scale up process later. * Preparation of Capex, Process Documentation File & BMR.* Process equipment selection with respect to process requirement, Safety & cost effectiveness* Facility creation according to the requirements.* Performed HAZOP review which includes failure mode effect analysis, critical parameters, process safety information and emergency preparedness.* Implementation of systems to comply with cGMP guidelines.* Trouble-shooting of the process during the trial phase of scale up.* Validation of process at plant scale.* Commercialization of process to a magnitude that meets future requirement.* Sent weekly report to all heads.* Successfully scaled up 3 products.* Good exposure on preparative HPLC (Column volume 125 L) operation.* Familiar with cGMP guidelines & Regulatory requirements.* Responsible for achieving performance measures for the month.* Worked in ERP environment and responsible for Product costing at the month end.* Work experience in CLEAN ROOM with class 100000 facilities

* In-Charge of shift activities* Sent Production performance & status report to the Production Head.* Responsible for achieving Performance measures for the month.* Process validation, BMR updation, Process Flow diagram, Risk Assessment register for new products.* Practiced ISO 9001,ISO14001, ISO18001 & cGMP norms in the plant* Work experience in CLEAN ROOM with class 100000 facilities which is operated by 0.3 micron HEPA FILTER AND LAMINAR FLOW FILTERS.* Producing the bulk drugs as per customer requirements particularly concentrating on the impurity present in the product and the residual solvents limits in PPM level based on the ICH guidelines.