Nilanchala Mahapatra

• Proved successful working within tight deadlines and fast-paced atmosphere.
• Exceeded goals through effective task prioritization and great work ethic
• Perform the internal Audits of all the sites
• Perform the Vendor audits related (RM and PM) and Review the CAPA provided by Vendors and issue the close out letter.
• Review the OOS, OOT, Deviations, Customer complaint investigations and proposed CAPA on need basis.
• Review the market complaint batches and provide the CAPA to the customer with coordination with site QA.
• Corporate SOP Draft procedure review for finalizing, conducting Trainings and ensuring the implementation of the corporate Procedures across responsible Cluster Units.
• Supporting Medopharm Units all the time readiness for the Regulatory Audits and Customer Audits.
• Reviewing the Preventive maintenance, Calibration executed documents by ensures the compliance on need basis.

• Day to day interaction with department HOD’s and in- charges and assigned the system improvement activities to meets the QMS requirements by Utilization of CQA Team.
• Review the OOS, OOT, Deviations, Customer complaint investigations and proposed CAPA
• Conducting the QRM and MRM (Cluster Units) and implementing the MOM Actions.
• Harmonizing the Operational procedures (Corporate QA/QC/Plant operational procedures (SOP’s) and practices across the responsible Cluster Units.
• Corporate SOP Draft procedure review for finalizing, conducting Trainings and ensuring the implementation of the corporate Procedures across responsible Cluster Units.
• Perform the internal Audits for API units across the APL on need basis.
• Perform the Vendor audits related to Formulations and API Units across the APL for qualifying the Suppliers.
• Supporting Cluster Units all the time readiness for the Regulatory Audits and Customer Audits.
• Reviewing the Preventive maintenance, Calibration executed documents by weekly/monthly basis and ensures the compliance for cluster units.

• Vendor audits for Internal API facilities for captive consumption and Contract laboratories.
• Review of Investigation of OOC/OOS/OOT/Incidents reports of all sites.
• Review of 21 CFR part 11 compliance instruments across the site.
• Review of data integrity compliance of sites periodically as per scheduled..
• Review of Instrument Qualification documents of all sites randomly
• Participate in Internal/External (Vendor) audits.
• Preparation of CQA policy and its implement in all sites.
• Timely intimate to all sites in case of Pharmacopeia updates

• Review Validation, processes Validation, Hold time study documents
• Method Transfer for Finished Products and API protocol preparation and Execution
• SAP and LIMS Activity of RM, PM and FP
• Preparation And Review of SOP,STP,GTP And SPECIFICATION

• Instruments and Equipments IQ/OQ/PQ Protocol preparation and Execution.
• Cleaning Validation, processes Validation, Hold time study analysis documents review
• SAP Activity of RM PM IP/FP/CAL
• Analysis of Stability Samples as per ICH guidelines & Stability testing of pharmaceutical relevant compounds of API and drug products as per ICH Guidelines
• Monitoring of Stability Chambers, Preparation of stability planner of the year and for the month
• Raising and Investigation of OOS/ OOT and Incidents in association with department head.

• Sampling of In-process , sampling of Validation Samples
• Providing line clearance during packing
• Checking of physical parameters during manufacturing
• Instruments and Equipments Validation Protocol preparation.
• Cleaning Validation, processes Validation, Hold time study analysis and review
• Method Transfer for All Finished Products and API protocol preparation
• Updating the pharmaceutical changes as per requirements.
• SAP And LIMS Activity of RM PM IP/FP
• Handling Laboratory Errors, deviation, Change control and OOS.

Attended the audits like MHRA, MCC, USFDA ANVISA etc