-Effectively lead team clinical release/ stability to deliver goals/results. Provides training and the necessary resources to lab management to meet department objectives.-Prepare and manage daily work schedules for QC analysts and assign the related activities to meet manufacturing and laboratory schedules and needs.-Review of HPLC, UPLC, Dissolution, Disintegration, and Water content raw data for completeness and preparation of stability compilation reports.-Preparation /Review of technical documents like SOPs, COA, STPs, validation protocols/reports etc.-Address any unusual observations according to the current quality system and initiate and investigate the completeness of proper QMS like Quality event, Incidents, OOS, OOC, OOE and OOT.-Review and management of standard and impurities, arrangement for the standards and COAs.-To ensure the preventive maintenance and calibration of instruments as per the schedule.-To ensure the system's compliance within the department and Provide training to analyst whenever required to improve the work flow and meet compliance.-Supports the execution of laboratory audit readiness program to ensure compliance ready state at all times in the laboratory.-Faced USFDA, FIMEA audits directly and involved in the clients audits.-Co-ordination with engineering, vendor, supply chain department for the smooth functioning.

-Method development of Assay, related substance, API verification and partial validation of analytical methods.-Exposure to Citrix and eLN writing.-Preparation of Analytical Method and protocol to support the routine analysis and plant.-Preparation of Method development reports.-Responsible for performing analytical activities for investigation, justification, compendial evolution, equivalency report and troubleshooting.-Literature search for Method development.-Force degradation study on API and formulation.-Preparation of compilation for various batches and products to observe stability trends.

-Worked with Method development of Injectable, oral solution and suspension.-Review of lab notebook, log book, protocol, validation and method development report of various analytical test.-Review of results of various analytical tests.-Compilation preparation of stability batches.-Method transfer activity to other plant.-Method development and validation of various tests.-Maintenance of various Columns, Standard and Impurity standard

- Associate with Analytical Method Development like Assay, Dissolution and Related Substance. - Performed routine as well as stability samples analysis for solid oral dosage form also partial validation of analytical methods for it.- Preparation of Analytical method development report as well as verification report.- API method verification.- Calibration of various instruments like HPLC, UPLC, Dissolution and disintegrater tester.- Solubility study as per BCS and saturated solubility.- Perform Excipient compatibility studies- Exposure to client business (CDMO)- Understand the need of client and to meet their timeline- Manage work flow of development work according to meet the timeline- Implementation of own understanding as well as client prospective to reach the goals- Support to client in various data generation for filling purpose and solve the queries related to filling process.- Procuring the need for project completion - Management of various standards and columns - Preparation of compilation for various development batches as well as scale up batches to observe the trend of product

Associate with Analytical Method Development of Assay,Dissolution and Related Substance. performed routine as well as stability samples analysis for dosage form like solid, oral solution and injectables also partial validation of analytical methods.

Handling Assay, Content and blend Uniformity, Dissolution of RLD samples as well as of Stability samples.Observe trend of formulation behavior throughout the stability study. Implementation of various extraction methods for drug content from formulation like cream, gel and oral solution.