 To ensure the provision and maintenance of a robust QMS-Quality Management System for pharmacovigilance  Development, including review and sign off of new and existing company SOPs, /WIs/Guides oversight of control and issue of SOPs internally and to clients including affiliates as required.  Preparation and review of client specific compliance matrix for the PV performance indicators and share it with QPPV and PV support managers  Review and Finalization of client specific… Show more  To ensure the provision and maintenance of a robust QMS-Quality Management System for pharmacovigilance  Development, including review and sign off of new and existing company SOPs, /WIs/Guides oversight of control and issue of SOPs internally and to clients including affiliates as required.  Preparation and review of client specific compliance matrix for the PV performance indicators and share it with QPPV and PV support managers  Review and Finalization of client specific Pharmacovigilance Management Plan (PMP)/ Matriovigilance Management Plan (MMP)/ Safety Data Exchange Agreements To provide updated data for Pharmacovigilance System Master File (PSMF) preparation and its revision.  To Manage the ongoing internal audit programme and support QPPV  To Support QPPV and Lead Auditor for Management of vendor audits and External/Client Audits including scheduling, hosting and follow up of systems audits.  Management of Regulatory Inspections and external audits and support to QPPV.  Monitor and manage the quality of documents produced by the department including the ICSRs, Aggregate reports and SOPs to meet both internal SOP standards and external regulatory standards.  Review of Deviation/CAPA/Change Request/Incident forms  Review of Void/Nullification/Unlock Drug/Device/Vaccine Addition Forms.  Review of client / departmental Agreements Show less

 Planning, coordination and execution of the analytical activity related to online data reviewing of analytical method validation documents, method transfer documents and analytical method protocol and query related data etc. For compliance & ensuring data integrity in R&D, Regulatory documents (USFDA) submission through Office of Data Reliability (ODR). Accountable for process harmonization in various sites along with QMS tools (Change Control, Deviation and Laboratory Incident). Review… Show more  Planning, coordination and execution of the analytical activity related to online data reviewing of analytical method validation documents, method transfer documents and analytical method protocol and query related data etc. For compliance & ensuring data integrity in R&D, Regulatory documents (USFDA) submission through Office of Data Reliability (ODR). Accountable for process harmonization in various sites along with QMS tools (Change Control, Deviation and Laboratory Incident). Review the online sequence, analytical data, electronic data, audit trail and their e-signature in Empower, ChromeLeon software with HPLC.  Responsible for reviewing the calibration data of HPLC, GC, LC-MS, GC-MS, UV-VIS-spectroscopy Dissolution, ICPMS, UPLC, Analytical Balance, UV spectrometer, etc. as per in-house SOPs  Ensured laboratory compliance to meet regulatory expectations for system software audit trail review, review of empower, and other electronic data as per 21CFRpart 11 Accountable for reviewing the:• To Schedule the Preventive Maintenance and calibration of device and instrument and maintain the track record• IQ/OQ /PQ data of new instruments like HPLC, Balance, GC etc.• PPV data of instruments as per schedule Devising plans and conducting the Lab Audit monthly and ensuring the corrective action Verifying numbers to laboratory, COA, and validation reports Responsible for device management (sent the device for calibration to an outside vendor and maintained the master device record) Facilitating induction and mandatory training for new joiners and maintaining their competency record as DTC (Department Training Coordinator) Verifying the sample number for analyst qualification to new and old analysts for new techniques and reviewing the same data Sharing the calibration observations with lab personnel and management on monthly basis Working with software like, LMS, EDMS, Laser fiche, BSMS, Nu-genesis, Empower3.7.0, Medhas, LIMS, Track wise, etc. Show less

Key deliverables: Conducted technical review of the raw data generated during the analysis of subject samples from BA/BE studies and chromatographic data of bio-analytical studies and method validation in conformance to Laboratory SOPs and GLP using Nu-Genesis software SDMS 7.1 Application (Review, Print, and Archive) Deployed a flow chart for the check process in the chromatographic review process Selected incurred samples for reanalysis and repeat samples Summarized… Show more Key deliverables: Conducted technical review of the raw data generated during the analysis of subject samples from BA/BE studies and chromatographic data of bio-analytical studies and method validation in conformance to Laboratory SOPs and GLP using Nu-Genesis software SDMS 7.1 Application (Review, Print, and Archive) Deployed a flow chart for the check process in the chromatographic review process Selected incurred samples for reanalysis and repeat samples Summarized final concentration data for pharmacokinetics and statistical evaluations Coordinated and Supported (clinical, bio-analytical, and clinical laboratory) during regulatory inspections, response preparation, etc. Reviewed bio study SOP and protocol and provided comments Identified the ways to simplify and improve the work process to achieve better results, data analysis, report generation, and appropriate utilization of resources Reviewed the calibration data of HPLC, LC-MS,GC ,Balances and dissolution apparatus etc. as per in-house SOPs Procured and maintained the references standard and working standard from different plant locations Show less

Key deliverables: Conducted technical review of the raw data generated during the analysis of subject samples from BA/BE studies and chromatographic data of bio-analytical studies and method validation in conformance to Laboratory SOPs and GLP using Nu-Genesis software SDMS 7.1 Application (Review, Print, and Archive) Deployed a flow chart for the check process in the chromatographic review process Selected incurred samples for reanalysis and repeat samples Summarized final… Show more Key deliverables: Conducted technical review of the raw data generated during the analysis of subject samples from BA/BE studies and chromatographic data of bio-analytical studies and method validation in conformance to Laboratory SOPs and GLP using Nu-Genesis software SDMS 7.1 Application (Review, Print, and Archive) Deployed a flow chart for the check process in the chromatographic review process Selected incurred samples for reanalysis and repeat samples Summarized final concentration data for pharmacokinetics and statistical evaluations Coordinated and Supported (clinical, bio-analytical, and clinical laboratory) during regulatory inspections, response preparation, etc. Reviewed bio study protocol and provided comments Provided technical inputs in reviewing relevant SOPs and the study protocol Imparted training to new employees and trainees Reviewed the calibration data of HPLC, LC-MS, GC, Balances and dissolution apparatus etc. as per in-house SOPs Procured and maintained the references standard and working standard from different plant locations Show less

Key deliverables: Conducted technical review of the raw data generated during the analysis of subject samples from BA/BE studies and chromatographic data of bio-analytical studies and method validation in conformance to Laboratory SOPs and GLP using Nu-Genesis software SDMS 7.1 Application (Review, Print, and Archive) Deployed a flow chart for the check process in the chromatographic review process Selected incurred samples for reanalysis and repeat samples Summarized final… Show more Key deliverables: Conducted technical review of the raw data generated during the analysis of subject samples from BA/BE studies and chromatographic data of bio-analytical studies and method validation in conformance to Laboratory SOPs and GLP using Nu-Genesis software SDMS 7.1 Application (Review, Print, and Archive) Deployed a flow chart for the check process in the chromatographic review process Selected incurred samples for reanalysis and repeat samples Summarized final concentration data for pharmacokinetics and statistical evaluations Coordinated and Supported (clinical, bio-analytical, and clinical laboratory) during regulatory inspections, response preparation, etc. Reviewed bio study protocol and provided comments Provided technical inputs in reviewing relevant SOPs and the study protocol Imparted training to new employees and trainees Reviewed the calibration data of HPLC, LC-MS, GC, Balances and dissolution apparatus etc. as per in-house SOPs Procured and maintained the references standard and working standard from different plant locations Show less

Key deliverables: Analysis of stability sample and raw API and varies dosage formulation. Prepared general laboratory SOPs as per regulatory guideline. Prepared and maintained calibration schedule for all the instruments in the section. Reviewed and compiled data generated from method validation and study sample analysis. Conducted routine calibration of HPLC, GC, Dissolution apparatus, FTIR, pH meter, Analytical balance, Polari meter and UV as per in-house SOPs.