Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Timeline
background-images

DURGA MISHRA

Bengaluru

Summary

Experienced professional seeking a challenging role in IT QA/CSV/Quality Auditor/QMS/Project Manager at a reputable organization. Dedicated to leveraging skills and innovative ideas for organizational growth. Committed to driving continuous improvement initiatives, delivering high-quality results, and exceeding expectations in a dynamic environment. Passionate about fostering a culture of excellence and collaboration to drive business success.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Senior Consultant – Project Quality Manager

Infosys Ltd
10.2021 - Current
  • As a Project Quality Manager (PQM) handling ERP IT, Commercial IT & Digital & Health Projects by using Optimize Waterfall and Agile Methodologies.
  • Ensure an effective compliance process is established and implemented during the process of software application development and maintenance.
  • Ensuring project specific process, procedures and work instructions are following, controlled and communicated effectively to the team.
  • Ensure industry standard and Regulatory requirements are fulfilled.
  • Defines the approach/strategy for End-to-End Validation projects (GxP/Non- GxP) for the applications.
  • Reviewing and monitoring adherence to the project specific process, procedures and work instructions.
  • Function as SPOC to manage Methodology issues, Deviations, Escalation point of contact during the roll outs.
  • Authoring (Validation Plan, Quality Plan and Validation Report etc.) and reviewing all project deliverables and life cycle documents.
  • Compliance review of all the validation documents (URS, FS, DS, CS, Risk Assessment, IQ, OQ, PQ scripts, TSR, Traceability Matrix etc.) for all SDLC/Project phases as defined in QMS/WI/SOPs.
  • Ensuring the project team follows quality deliverables and timely closure of CAPA.
  • Co-ordinate with key stakeholders (QA/Project Lead/PMs/Stee Co) on various project aspects like, communication, alignment and defining the milestones. Also, facilitates the phase review meetings with key stakeholders.
  • Ensuring the Waterfall and Agile approach has been followed in the projects as defined in the SOPs for different services (ERP IT & Commercial IT).
  • Ensuring each project should have completed the CAIRO Assessments (Security Risk Assessment, Third Party Assessment and Data Privacy Assessment).
  • Responsible for reviewing and approving the Audit trail, Periodic review, backup & restoration, Disaster recovery, User management and access, Privilege management access of the GxP software systems of R&D department as an Application Quality Manager (AQM) for certain period.
  • Support the execution of third-party quality assessment and audits.
  • Project Information: (Client- Alcon)
  • Auto store Project (Integration with SAP ECC, PI & MII)- Belgium
  • Implementing Siemens OpsCenter at Singapore AML Chemical Plant (Build new interfaces for Manufacturing, SCM & QA processes with Siemens OpsCenter using MII & PI as Middleware).
  • Archiving the legacy ERP data from legacy ERP applications and making an identical copy of the data in Informatica ILM platform used the existing archival set-up.
  • Aerie Integration Project (Added 4 legal entities to IRIS system)
  • Consolidation of distribution and creation of a new decentralized Regional Distribution Center (RDC) in Eastern EU (CZ) with APL owned inventory and direct to customer shipments for 3 markets namely Czech Republic/Slovakia, Hungary, and Poland (CZ/SK, HU & PL).
  • ACESX
  • MS360
  • Service Portal

Assistant Manager-CQA (IT Quality & Compliance)

Syngene International Ltd.
09.2020 - 10.2021
  • To review Quality system and ensuring the cGMP compliance at site of GMP/GLP/GCP Software systems like ELN, RT-PCR.
  • GxP assessment, ER/ES applicability assessment and GAMP categorization classification, Qualification (IQ, OQ & PQ based on 21 CFR & EU Annexure 11) of GxP systems based on life cycle approach and release of GxP system for operational use.
  • Handling different projects of multiple verticals like GMP/GLP/GCP by using SDLC policy (V-Model validation approach).
  • Responsible for reviewing and approving of all CSV deliverables like Impact Assessment, System Classification Assessment, Validation Plan/Qualification Plan, User Requirement Specification, Functional Specification, Design Specification, Configuration Specification, Traceability Matrix, IQ/OQ/PQ (Test plan, test cases, test runs), Discrepancy/Defects, if any, Test Summary Report, System Release Certification as per USFDA, EU Annex 11, 21 CFR Part 11 & GAMP 5.
  • Ensuring the IT Governance like IT SOPs review, gap analysis and auditing.
  • Responsible for reviewing and approving the QMS like Change control, deviation, CAPA related to IT department.
  • Authoring of the SDLC policy
  • Review and approve of use cases, Test plans, Test Scripts, and Test metrics.
  • Support the review of new systems & modifications to legacy systems to ensure designs comply with current validation standards and can be adequately validated and maintained within validated control.

Assistant Manager-CQA (IT, Manufacturing & QC Compliance)

Micro lab Pvt. Ltd
04.2019 - 09.2020
  • To review Quality system and ensuring cGMP compliance at applicable sites (ML03 & ML01).
  • To review and approval of documents related to Quality Management System and trend reports (Change control, CAPA, Deviation, Market complaint, APQR, OOS, OOT, Stability reports, Qualification documents like CSV, Cleaning, Equipment & Utilities) at applicable sites.
  • To handle Regulatory and other Customer Inspection at applicable sites in coordination with site QA head.
  • To conduct Quality Management Reviews and Monthly Quality System Review (QSR) meetings with Corporate QA head.
  • To conduct Internal Audits at Sites of different departments as a Certified Quality Auditor.
  • To conduct Data Integrity audits at sites and to reports the audit outcome to Head of CQA.
  • Review of the new manufacturing and quality control equipment’s, modified/re-constructed existing manufacturing area /new area qualification protocols and reports.
  • Reviewing of the software validation protocols and reports of quality control department.

Assistant Manager-QA

Dr. Reddy’s Laboratory
07.2014 - 01.2019
  • Handling and updating of routine cGMP documents like Change Management System, Deviations, CAPA Management system, Audit Management (Internal as well as external), Quality Risk Management (ICH Q9), Root Cause Analysis (RCA), Investigations.
  • Leading the IPQA team of 8 members and handling the Quality Management System of manufacturing, packing, warehouse, and quality control departments.
  • Preparation, review, and control of Master documents (SOP, SMF, VMP, CVMP).
  • Preparation, execution, compilation of Cleaning Validation, Matrix, protocols & reports.
  • Preparation of Annual Product Quality Review and Statistical Evaluation of all the critical quality attributes and critical material attributes of each product.

Officer-QA

Mylan Laboratories
08.2013 - 06.2014
  • Authoring of the quality related SOPs like Batch Release, APQR, Change Control, Deviation
  • Handling of Warehouse (Dispensing, Batch Release, Review of Materials reconciliations) & QC department (Handling of OOS, OOT Investigations, Monitoring Stability Management, Microbiology).
  • To conduct Internal Audits of different departments like manufacturing, warehouse, quality control, IT, engineering, safety as a Certified Quality Auditor along with cross-functional department heads.
  • Handling of QMS activities like Change Control, Incidents, CAPA, investigations through Track wise Software.
  • Expert in mapping temperature and relative humidity of warehouse department along with protocols.

Executive QA

Medopharm Pvt. Ltd. (Beta-lactam Plant)
08.2010 - 05.2013
  • Handling of routine activities of manufacturing, packing and warehouse department (Dispensing of Raw material, Packing material and solvents).
  • Directly involved in Audit Compliance of MHRA, UGANDA, WHO
  • Ensuring on-line documentation of the BMR, BPR, hold time study protocol/report, Process and packing validation protocol/report adhere to the quality and c-GMP Compliance as per the regulatory requirement.
  • Sampling of routine commercial and validation batches at different stages like Blend, Compression, Coating, Capsule Filling, Primary & Secondary Packing (Tablets, Capsules, Dry Syrups dosage form).
  • Ensuring the In-Process Quality Control Tests (IPQC) of different stages of Samples like Disintegration Test, Sieve analysis, Bulk Density, Hardness, Friability, Weight Variations, LOD/Moisture Content, Leak Test etc.

Education

M. Pharm - Pharmaceutics

SOA University
Bhubaneswar, Odisha
01.2010

B. Pharm - undefined

BPUT University
Bhubaneswar, Odisha
01.2008

Skills

  • Software quality assurance
  • Proficient in CSV handling
  • Regulatory compliance expertise
  • Quality management processes
  • Risk assessment and mitigation
  • Regulatory compliance oversight
  • Mentorship facilitation
  • HP ALM expertise
  • ServiceNow expertise
  • JIRA project management
  • Proficient in Confluence
  • Qtest proficiency
  • Strong interpersonal skills
  • Proficient in SAP DMS
  • SAP Change Request Management

Certification

  • Agile Methodology- Coursera
  • Introduction to Cyber Security- Simplilearn
  • ISO/IEC 27001 Information Security Management System- Udemy
  • PMP certification- Udemy & Simplilearn.
  • Infosys (In-house)
  • Agile Scrum team member
  • AI-First Software Engineering Ethical- AI
  • Generative AI-Landscape
  • Prompt Engineering
  • Responsible AI- Foundation
  • Responsible AI Practitioner
  • CSA training
  • HP ALM
  • Quality & CSV

Accomplishments

  • Received Insta Award from Infosys for the valuable contribution in PQM/AQM role.
  • Received Client appreciation for completion of project with quality compliance within stipulated time- line.
  • Received special appreciation awards from QA head for identifying various critical non-compliances in shop floor.
  • Spot recognition award for 5 times for identifying the critical discrepancies during (qualification of software) review of CSV deliverables.
  • Identified various non-compliances during export checking and got Spot recognition from Head QA.

Timeline

Senior Consultant – Project Quality Manager

Infosys Ltd
10.2021 - Current

Assistant Manager-CQA (IT Quality & Compliance)

Syngene International Ltd.
09.2020 - 10.2021

Assistant Manager-CQA (IT, Manufacturing & QC Compliance)

Micro lab Pvt. Ltd
04.2019 - 09.2020

Assistant Manager-QA

Dr. Reddy’s Laboratory
07.2014 - 01.2019

Officer-QA

Mylan Laboratories
08.2013 - 06.2014

Executive QA

Medopharm Pvt. Ltd. (Beta-lactam Plant)
08.2010 - 05.2013

B. Pharm - undefined

BPUT University

M. Pharm - Pharmaceutics

SOA University

Similar Profiles

CREATE PROFILE
DURGA MISHRA