Roles and Responsibilities :

• Literature review, patent evaluation, pre formulation study.
• Innovator/ market sample evaluation, labs scale batches/ trials, optimization batches and reporting all trail details in PDR / LMB.
• Stability study, planning pivotal batches and conducting same in labs and plant.
• Preparation of scale up batch, process qualification batch documents and conducting same in plant facility.
• Preparation of documents for regulatory filing as per target market (US/ EU/ AU) for new product.
• Preparation of tech transfer documentation like change control, new product introduction, master manufacturing formula, bill of material and product development report for domestic market.
• Preparation and checking of master manfacturing document, MFR, PDR, process validation report, process validation protocol, checking feasibility parametersin registered specification for domestic market and conducting optimizationand exihibit batches for domestic market.
• Conducting exihit batches in plant according to cGMP.
• Operating and maintaining equipment and instruments as per SOP.

Education: M. Pharma in Any Specialization

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