To understand the accurate demand for the development of the project (i.e. NCE/Regulatory markets/Domestic market/Cost reduction/Captive or External requirements) and plan the development sequence to meet the timelines and quality.
To do infringement analysis w.r.t. available literature and reports received from the IPR team(i.e. process/polymorphs/impurities/other parameters)
To design the routes of synthesis based on infringement analysis.
To communicate with the purchasing team to provide the price of Raw material price based on the quantity provided in PIF for paper costing for designed ROS.
To prepare a budget and timeline for the project execution.
To identify and indent RM/KSM/Intermediates to start the feasibility.
To review/generate the force degradation data with the continuation of feasibility.
To prepare a feasibility report to finalize the most suitable route to proceed for optimization.
Submit the project initiation form to the Analytical team with a brief introduction of the project.
Ensure that indicative stability studies are started and monitored timely at each appropriate modification of the process.
To optimize the process with respect to different variables and factors using different techniques QBD/What if analysis/Risk assessment to meet ICH requirements. (Q3D/M7/Q8)
To ensure the compliance of LNB and to review analytical data closely.
To identify critical material attributes(RM Specification) and critical process parameters which is directly impact to CQA.
To prepare an optimization report based on studies with highlighted the CPP, CMA, and CQA of RM/Intermediates and in-process parameters with justification(based on fate purge, fate map of impurities and design space of variables)
To ensure the fulfill the requirement of working standards/reference standards/impurities.
To identify the cost-contributing factors and replace them with economical reagents to be the most cost competitive.
Review and sharing of all experimental data regarding process parameters and challenging experiments with the Technology transfer team.
To update day-by-day activity to respective team leaders.
Scale-up and Validation Responsibilities:
To prepare a risk assessment of process w.r.t. safety and quality parameters.
To initiate a discussion with the TT team for the scale-up of the project in Kilo lab w.r.t. critical operations and quality parameters briefly.
To review BPR, Norms, and PID prepared by the TT team for scale-up in the Kilo lab.
To review scale-up reports after kilo lab studies.
To revise process parameters or quality parameters based on kilo lab studies if required.
To prepare and review quality plans/specifications of RM/KSM/Intermediates/in-process controls/Recovered solvents/2nd crop and share with the DQA team with proper justification, data, and impact assessment(in case of change in the specification).
To prepare a lab validation protocol for fresh solvent batches/recovered solvent and 2nd crop batch if applicable.
To review the indicative stability study and finalize the storage conditions and packaging materials.
To initiate validation batches for the stability/hold time with finalized packaging materials condition according to ICH(different zones).
To ensure the fulfill the requirement of samples for Analytical method validations/reference standards/impurities.
To provide the all required data and write-ups for the technology transfer document preparation
To ensure process risk assessment preparation and mitigation plan for high-risk operations.
Plant validation responsibilities:
To review Documents related to Plant scale such as BPRs, Validation Batch Protocols, and Validation Reports.
To participate with the plant team to transfer knowledge of CPP and safety precautions.
Coordination with the Technology Transfer Team, Plant Production Team, and Plant QA team regarding Documentation and sharing of experimental data and stability reports.
To run performance trials with planned raw materials before starting Pre-validation batches.
To ensure the close observation of plant batches along with the technology transfer team.
To provide a technical investigation of OOS/OOT, if observed during plant validation/commercial batches.
To prepare investigation reports with the scientific root cause and suggestions of CAPA.
Quality Compliance and Regulatory Responsibilities:
To ensure the documentation and review of daily experimental activities in LNB with analytical data.
Ensure the calibration of lab equipment along with documentation.
Designing and review of all specifications & quality of Raw materials, Intermediates, and drug substances/recovered solvents/im-process controls/2nd crop.
Preparation, supervision, and review of complete documentation related to process development, working standards, impurity standards, and stability protocols.
Coordination with the RA team, ARD team, Purchase team, and Vendor for Harmonization of Specification of all KSMs and RMs.
Preparation of risk assessment reports(Elemental/Genotoxic assessment/Nitrosamine/organic impurities and others) based on requirements.
To plan the activities to respond to the queries of USDMF/EDQM or others within the timelines.
Enhancement of GDP to improve compliance in developed environments.
Preparation and review of important documents related to QMS/RA anticipated queries.
Responsible for Lab management, degradation, and maintenance in a presentable state.
Ensure the maintenance/calibrations of all lab equipment with log books.
To ensure the arrangement of chemicals in a safe way according to their MSDS with the list and update the list timely to identify the accurate place of chemicals.
Maintenance of all lab activities including Lab cleanliness and safety day by day to avoid incidents.
Ensure the procurements of equipment and chemicals with the purchasing team timely.
To ensure a sufficient inventory of chemicals/glassware/stationery items.
To ensure the strict following of Lab safety measures and give training to subordinates.
To ensure the disposal/quenching of unwanted chemicals or reagents.
