R&D | Formulation Scientist

Documentation activities

• To prepare Technology Transfer documents: LIF, PIF, PBOM, BOM for VAQ review, FBOM, MFC, etc.
• To initiate AIF and Change control in portal
• SAP related activities: BOM loading, New SAP code generation activities, Code extension and other SAP related activities
• LnB Issuance, PDR review, LnB and Project Files Archival
• SOP preparation, review and training
• Form 29, Form-11 application activities and tracker update.
• To prepare DCGI documents for products harmonized with regulated markets.

Product development

• To carrryout literature search on the assigned projects
• To monitor and ensure the availability of raw materials, API and PM as per need
• To align and carryout formulation development activities as per timelines and requirement
• To prepare presentations of the assigned projects and discuss with GL at different stages of development.
• To load the products in stability study on time
• Monitoring and discussion of the stability data
• To ensure the online LNB writing and its compliance
• To prepare regulatory (DCG(I) submission documents and to align the activities for the approval by DQA
• To follow the SOPs / Guidelines in the lab area during practical work
• To align and carryout technology transfer activities (Execute exhibit & validation batches) at manufacturing site as per timelines and requirement
• To carry out any other additional / specific work given by the section head / department head

Collaboration & coordination

• To co-ordinate with other supporting departments like ADL / PKG. / RA / GDSO / CQA for day-to-day activities as required.

Team Training

• To deliver a presentation on assigned topic / execution learnings (case study) within the team