Execution of NCE projects, generic projects and line extension projects using QbD principle.
Preparation and/or review of literature summary and development report to the assigned product.
Involve in execution and/or supervision of formulation development, process development and manufacturing of GMP batches to the assigned product.
Preparation and/or review of technical documents like MFC, BMR, BPR and Stability protocol etc. following the GDP.
Follow GxP (GMP, GDP etc. ) for all processes and train the subordinates to follow the same.
Execution and/or supervision of scale up and pilot batches in pilot under GMP condition.
Preparation and/or review of technical documents like, product development report, batch manufacturing record, technology transfer documents etc. and transfer of technology to manufacturing site, if required.
Preparing/reviewing/approving the QMS documents like change control, deviation and out of specification.
Communicating with cross-functional team and client via mails and meetings.
Performing and/or supervision calibration and maintenance of R&D instruments and equipment
Procuring / indenting materials and machines change parts related to concern projects
Maintain safe and hygienic condition in respective department
Ensuring the use of personal protective equipment whenever required during batch execution
Attending training related to FD, EHS and QA (if applicable)
To complete any task or projects given by management or organization for product development and organization improvement.
All generated waste to be sent to concerned person and must be comply with EHS requirements
Communicating and interacting with international and national clients
