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AMN Life Science Pvt. Ltd. looking for Formulation Development Manager ||Apply Now
We are looking for Formulation Development Manager
Job Location : Kala amb Himachal Pradesh
Qualification : M. Pharma
Job Description :
Development of new product as per regulatory guidelines and documentation as per GDP.
Discussion with all CFT for new product development and their requirements. API, excipients and Innovator characterization and finalization by reviewing their respective COA.
Reviewing Patents, research and review articles for new product development.
Design and Planing of preformulation studies as per findings from literature search for new products as per ICH guidelines.
Designing, Planning for execution and finalization of trial batches according to the trial findings for new products. Analytical data review for finalization of in process and finished parameters of new products.
Packing development and packing finalization of trial batches Risk assessment preparation, stability protocol preparation and planning for stability charging of final trial batches as per ICH guidelines.
Designing, Planning and to ensure execution of process optimization batches of final F&D trial batch. Review of all raw material issue sheet, trial sheet and there batch
numbering.
MFC review for finalization of all critical process parameters and according approved packing art work Planning of PDR preparation and Review of PDR Review and approval of change control related to new product development and any other changes related to product.
Batch size finalization as per production area requirement or marketing order and Scale up calculations for exhibit/validation batches as per production equipments. Planning and execution of exhibit/validation batches as per proposed parameters.
Review and approval of Hold time protocol, Exhibit/validation protocol and Exhibit/validation report. Finalization of Recommendation after Exhibit/validation batches and related CAPA Training of department personal on monthly basis for respective SOPs.
Troubleshooting of routine validation/commercial batches. Review and Approval of all DQA related activity in F&D and ADL Ensuring existing machine change parts, requirement of new machine or equipment, timely machine calibration, timely availability of API and excipients for product development
Interested can email resume at
rajeev.sharma@amnlife.in
or Contact at 9218584845
