PRAGNESH SHAH

Manager I (Section Head)

• Job Details:Handle a 5 employee team. Leave approval, time office approval. Yearly performance appraisal discussion. Work planning, supervision, and discussion related to all validation activities (working with non-oral products like depot, peptide, injectable, API, and liposomes products). CFT communication regarding analytical method critical discussion, method modification, and resource arrangement. Provide suitable timelines to complete product analytical method validation, analytical method transfer, RLD batch analytical activity, and query work. Identify and discuss analytical method issues and resolve by tweaking method. Use Trackwise for lab events, planned deviations, CAPA, hypothesis creation, investigation updates, and closure. Implement effective systems in the lab for proper handling. Track calibration activities of all instruments under the non-oral department. Review analytical method validation protocols and reports, technical reports, justification reports, LNB reviews, and spreadsheets. Arrange resources and develop people.

Manager I (Team Leader)

• Job Details:Plan and supervise all studies of allotted microsphere/depot projects, schedule project-related analytical work as per timelines. Distribute work among team members. Troubleshoot and solve product-related queries as required by regulatory agencies (US, EU, Brazil, rest of the world). Check analytical reports and maintain the lab. Draft and develop effective analytical methods for excipients, API for depot, liposome, and injectable products. Prepare protocols and reports for analytical method validation. Develop and validate various analytical methods like assay/content uniformity, related compound, and in vitro release particle size for depot, liposome, and injectable projects. Train junior and new employees.

QC Executive

• Job Details:Conduct stability indicating assays, related substances, dissolution profiling, and particle size determination by wet method. Analyze assays, related substances, dissolution, and particle size determination for stability and plant batches. Conduct literature surveys, method validation, dissolution profiling for depot products, routine testing, troubleshooting, work planning for subordinates, and review and compile analytical data.