Senior Research Associate-FD
- Formulation development of NCE projects, generic projects and line extension projects
- Preparation/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 of assigned product.
- Preparation/review of technical documents, which includes but not limited to MFC, BMR, BPR and Stability protocol following GDP.
- Representation in departmental audit
- Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.
- Execution and/or supervision of scale up/pilot scale batches in pilot plant under GMP condition.
- Preparation and/or review of technology transfer documents and technology transfer to manufacturing site, whenever required.
- Preparing/reviewing of QMS includes but not limited to change control, deviation, SOPs and OOS
- Communication with cross-functional team and client via mails, meetings and oral communication
- Provide training on but not limited to SOPs, technology, guidelines and project specific activities
- Performing and/or supervision calibration and maintenance of R&D instruments and equipment
- Procuring 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, QA or any other department (if applicable)
- Ensure comply with EHS requirements while working in FD lab and Pilot plant.
- Support to proposal preparation for upcoming new projects
- Support to any additional responsibility/activity within or other department as and when required
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