• To review/verify all type of documents generated in R&D and in QC laboratory e.g. Analytical raw data, TDS, COA, Instrument calibration reports, working standard qualification and analyst qualification documents.• Involve in reviewing of analytical data, AMD, AMV, AMT, PDR, and Process Validation data reports with quality Control team and R&D team; link gaps and facilitated the development and implementation of corrective and preventive actions which enhance Data quality as per relevant guideline.• Management and handling of deviations, change controls, market complaints, events, CAPA, OOS, OOT, Risk Assessment and its effectiveness monitoring through Caliber QMS and Training and Co-ordination with Analytical Validation Laboratory, RA, IT, Engineering department and other stakeholders.• Preparation of audit compliance review reports of Internal / External (regulatory, Customer) audits for updating of point wise compliance status and tracking of corrective action and their effectiveness monitoring.• involve in audit trail verification/ Computer system validation/ online verification of User privileges matrix/ SOP preparation/Training and its compliance.• Coordinate and conduct required investigation for any reported OOS results / deviation / OOT results / quality risk management /product recall / market complaints / stability failures and prepare detailed investigation report.

• Involved in verification of the analytical data related to method transfer/ verification/ validation Protocols, Routine analysis/Waivers and Reports/analytical data/SOPs preparation/ instrument Calibration & Qualification / formulation development /PDR report etc.• Quality Management systems (QMS): Handling of QAMS for Change control/CAPAs/Deviations/Investigations/Incidents/Training and Co-ordination with Analytical Validation Laboratory, RA, IT, Engineering department and other stakeholders.• Established system audits, recognize gaps, and implemented corrective actions to achieve USFDA certification in Plant and R&D Centre as a Site representative for USFDA audits.• Managed caliber QMS, DMS& LIMS; for management of overall compliance level at Site.• Performed audit compliance reviews for internal and external audits, updating compliance status with expert analysis and reporting.• Involved in execution of software CSV qualification (IQ, OQ, PQ) activities, ensuring software compliance and enhanced the overall compliance by which reduced audit observations.

• Quality management systems (QMS): handled Change Control requests, CAPA's, deviations, investigations, and Incidents. • Involved analytical validation of methods, transfer and verification of different instrumental techniques, such as HPLC, GC, and UV.

• Established validation of analytical methods, transfer & verification and routine analysis of FG, stability, and RM release related activities using by instrumental techniques, such as HPLC, GC, and UV.

• Analyzed solid and liquid dose forms using HPLC, GC and UV techniques in Finish Good & Stability Section.