Source description
About the role
Dear Candidates , Greetings from Yochana, We are looking for Technology Transfer Excutive--Chennai. Role & responsibilities Responsible for monitoring of Trial, Scale-up, Exhibit, Pre-validation, Process verification and Validation batches. Responsible for monitoring of trial, scale up, exhibit and validation batches. To evaluate and prepare gap analysis for site transfer batches and provide risk assessment for the same. To prepare, review and Hold time protocols and hold time reports Prepare summary report for the batches manufactured. Co-ordinate with R&D and Production for smooth transfer of Technology from exhibit batch to production scale-up. To manufacture lab scale trial batches and process optimization trial batches in R&D. Co-ordinate with R&D, Production, Quality Assurance, Analytical R&D, Quality control for smooth transfer of Technology from exhibit batch to Production scale. To follow the standard operating procedures and safety precautions. Trouble shooting activities to be performed (if any) during the manufacturing of exhibit batches, validation / commercial batches. To support in activities related to costing and manufacturing feasibility verification. To finalize the batch size for scale up, exhibit, commercial batches and provide bill of materials & quantities. To provide safety data sheet for the products manufactured and trade dress for the products manufactured. To evaluate feasibility changes in product life cycle management. To provide justification reports for OOS, OOT, Deviation and Temporary changes with respect to Exhibit, Commercial manufacturing. To prepare Technology Transfer Dossier. Preferred candidate profile Exp:- 5plus years Qulaification:- Bpharma Interested candidates can share resume on rajini@yochana.com/7396610928.