- Literature search, selection of synthetic route after discussion with a superior, primary review on infringement/noninfringement of process, literature costing.
- Safety Co-Ordinator of R&D and to ensure safety training to workers in R&D and ensure the overall safety in CRD.
- Ensure the equipment used in R&D is standard made and calibrated for use and also ensure that preventive maintenance from time to time.
- To involve deeply in process development work and daily lab activities to develop and improve the skill of the Research Executive and Research Officer.
- Provide technical support when developing the process of new products and troubleshooting existing products/plant support. To involve in the OOS/OOT investigation and its report preparation.
- Process development and impurity profiling in API, review the lab-developed process, diligently observe critical process parameters, check lab notebook, and if required do correct form.
- Exhibit the developed process in the pilot plant and fulfill plant validation activities and support to achieve target yield and quality.
- To follow General Lab Practices (GLP) and train the other employees accordingly.
- To make various documents i.e., Technology Transfer Document (TTD), Drug Development Report (DDR), and project report for submission of various customer/Govt Bodies/Regulatory Authorities.
- Maintain systems documents i.e., QMS /EMS /OHASAS as applicable face the audits from internal/external time to time, and close the non-compliances.
Desired Candidate Profile
- Candidate must have R&D synthesis experience with 5 to 10 years in the API Pharma Manufacturing industry.
Qualification: B.Sc, MS/M.Sc Chemistry