Hi, I’m
MANIKANTA KUMAR
Hyderabad
Summary
About 12 Years of experience in the consulting and Pharmaceutical Industry with extensive experience in Time Management, Effective Planning, Efficient Task Coordination’s, Solid Organizational, Skills, demonstrated ability to lead a group of people, Inspiring Team Members, Key Decision Making to meet and achieve the daily / monthly / yearly goals and objectives of company.
Successful track record of handling site-level Quality assurance functions in API & injectable. Creation of state-of-the-art greenfield API facility with fully automated and digitalization capabilities. Participated in various regulatory audits like USFDA, MHRA, ANVISA, TGA, Health Canada, PMDA, WHO etc. Strong knowledge in technical Qualification and CSV projects, Planning, Supplier Assessment, Review, Approval and Compliance of CSV, SAP S/4 HANA CSV / Data Integrity Compliance / Production / Laboratory System Validation, Technical Qualification, and Audit Compliance to ensure compliance with global health authorities with minimal remarks.
Ensuring compliance in accordance with all CGMP and safety requirements, SOPs and company rules, regulations, policies, and procedures.
Overview
12
years of professional experience
Work History
Accenture Solutions Pvt. Ltd.
IT - System Manager - Business Architecture Team Lead (CSV, GRC & Compliance)
10.2024 - Current
Job overview
- Company Overview: Representing a global pharmaceutical leader with 100,000+ employees.
- Drive end-to-end Computer System Validation (CSV) ensuring regulatory adherence for the system's like Global learning management system (Saba LIMS).
- Manage lifecycle of validated systems in a highly regulated environment.
- Lead incident, change, and risk management activities for critical IT systems.
- Oversee supplier qualification, audits, and ongoing governance.
- Ensure continuous system monitoring and performance optimization.
- Collaborate with global cross-functional stakeholders across multiple geographies.
- Execute ITOM and ITSM practices to maintain operational excellence.
- Support implementation of new-age, AI-enabled compliance and monitoring solutions.
- Representing a global pharmaceutical leader with 100,000+ employees.
Wipro Technologies Ltd.
Sr. Consultant (Sr. Software Engineer)
05.2023 - 10.2024
Job overview
- Company Overview: Represented IT Compliance for a US-based global pharmaceutical organization.
- Validated computerized systems per client policies, GAMP 5, and 21 CFR Part 11.
- Worked with tools like ALM, q-Test, Kneat for e-validation practices.
- Validated systems including Qlik Sense, One Track, Sample Manager (LIMS), Pomsnet, Windchill (PLM), and Artwork Management systems.
- Represented IT Compliance for a US-based global pharmaceutical organization.
PwC India (Payroll: Harjai Computers)
CSV Manager
10.2022 - 04.2023
Job overview
- Planned, prioritized, reviewed, approved, and ensured compliance for CSV deliverables.
- Managed suppliers/vendors/clients and met delivery deadlines.
- Coordinated with stakeholders and internal teams for project execution.
- Performed data collection and GAP assessment of computerized systems.
- Oversaw validation of QC instruments and systems like Empower, Lab solutions, Tiamo, etc.
- Maintained and validated manufacturing systems with DCS/PLC/Track and Trace.
- Performed gap assessments for legacy systems and validated upgrades per regulations.
- Led digitalization projects from concept to validated state.
Emcure Pharmaceuticals Limited
CSV Specialist
11.2021 - 10.2022
Job overview
- Validated TrackWise (eQMS), LIMS (Microbiology), BMS, and SCADA/PLC manufacturing systems.
- Maintained master list of applications and conducted periodic reviews.
- Authored SOPs for CSV, 21 CFR Part 11, backup & restore, BCP/DR, audit trails, etc.
- Reviewed validation deliverables like URS, FRS, and configuration documents.
- Executed test protocols and validation summary reports per regulatory requirements.
Swaasa Pharma Limited
Asst. Manager - QA
11.2020 - 11.2021
Job overview
- Involved in CSV activities for a new API manufacturing facility.
- Validated lab instruments with Lab Solutions Server.
- Maintained master application list and performed periodic reviews.
- Audited external labs and reviewed quality agreements.
- Reviewed calibration/preventive maintenance plans, daily IPQA, BPCRs.
- Managed incidents, deviations, change controls, and OOS handling.
- Reviewed site master files, validation documents, and water/cleanroom validations.
Solara Active Pharma Sciences Limited
Executive - QA
11.2019 - 10.2020
Job overview
- Involved in CSV activities for greenfield API facility.
- Validated DCS (Emerson), TrackWise, LIMS, SCADA, PLCs, lab systems.
- Maintained master application list, conducted periodic reviews.
- Authored SOPs, URS, DQ, IQ, OQ, PQ for critical utilities (WFI, HVAC, etc.).
- Prepared process validation protocols and reports.
Dr. Reddy’s Laboratories / Therapiva Limited
Team Member - QA / Executive - QA
05.2013 - 10.2019
Job overview
- Participated in CSV activities for API facilities.
- Validated DCS (Emerson), LIMS, SCADA/PLC, lab instruments.
- Audited vendors and reviewed quality agreements.
- Executed facility qualifications, utility qualifications (WFI, HVAC, etc.).
- Handled vendor qualification, SOP revisions, and supported audits.
- Conducted validation for cleaning, drying, technology transfers, etc.
Education
Tata Institute of Social Sciences
B.Voc from Pharmacology & Pharmaceutics
01.2018
University Overview
GPA: 8.2 CGPA
GITAM University
Diploma from Certificate in Pharma Process Technology
01.2013
University Overview
GPA: 89%
Cherukupalli Junior College
Intermediate from M.P.C
01.2011
University Overview
GPA: 67.3%
Govt. High School, Kavur
S.S.C from S.S.C
01.2009
University Overview
GPA: 72.8%
Skills
- Computerized System Validation
- Life cycle documentation
- Validation processes
- Validation Plans
- URS
- HRA
- FRS
- DS
- SOPs
- DQ
- IQ
- OQ
- PQ
- Traceability Matrices
- Validation Reports
- 21 CFR Part 11
- EU Annex 11 assessments
- SDLC models
- Waterfall
- V-Model
- Agile
- Technical writing
- Validation testing
- Audit compliance
- Regulatory inspections
- Periodic review
- Defect handling
- Deviation handling
- CAPA management
- Data migration
- System retirement
- SaaS
- PaaS
- IaaS
- Effective communication
- CSV trainings
- Compliance activities
Profile Summary - Summary
About 12 Years of experience in the consulting and Pharmaceutical Industry with extensive experience in Time Management, Effective Planning, Efficient Task Coordination’s, Solid Organizational, Skills, demonstrated ability to lead a group of people, Inspiring Team Members, Key Decision Making to meet and achieve the daily / monthly / yearly goals and objectives of company. Successful track record of handling site-level Quality assurance functions in API & injectable. Creation of state-of-the-art greenfield API facility with fully automated and digitalization capabilities. Participated in various regulatory audits like USFDA, MHRA, ANVISA, TGA, Health Canada, PMDA, WHO etc. Strong knowledge in technical Qualification and CSV projects, Planning, Supplier Assessment, Review, Approval and Compliance of CSV, SAP S/4 HANA CSV / Data Integrity Compliance / Production / Laboratory System Validation, Technical Qualification, and Audit Compliance to ensure compliance with global health authorities with minimal remarks. Ensuring compliance in accordance with all CGMP and safety requirements, SOPs and company rules, regulations, policies, and procedures.
Skills - Computerized System Validation
- Strong exposure to life cycle documentation, tracking, and monitoring of validation processes.
- Skilled in preparing/reviewing validation documents including Validation Plans, URS, HRA, FRS, DS, SOPs, DQ, IQ, OQ, PQ, Traceability Matrices, and Validation Reports.
- Expertise in 21 CFR Part 11, EU Annex 11 assessments.
- Experience across SDLC models: Waterfall, V-Model, Agile.
- Proficient in technical writing and validation testing.
- Support for audit compliance and preparation for regulatory inspections.
- Periodic review, defect/deviation handling, CAPA management.
- Knowledge of data migration and system retirement.
- Familiar with SaaS, PaaS, IaaS models and their validation.
- Effective communication with stakeholders and internal/external teams.
- Delivered CSV trainings and supported compliance activities.
Timeline
IT - System Manager - Business Architecture Team Lead (CSV, GRC & Compliance)
Accenture Solutions Pvt. Ltd.
10.2024 - Current
Sr. Consultant (Sr. Software Engineer)
Wipro Technologies Ltd.
05.2023 - 10.2024
CSV Manager
PwC India (Payroll: Harjai Computers)
10.2022 - 04.2023
CSV Specialist
Emcure Pharmaceuticals Limited
11.2021 - 10.2022
Asst. Manager - QA
Swaasa Pharma Limited
11.2020 - 11.2021
Executive - QA
Solara Active Pharma Sciences Limited
11.2019 - 10.2020
Team Member - QA / Executive - QA
Dr. Reddy’s Laboratories / Therapiva Limited
05.2013 - 10.2019
Tata Institute of Social Sciences
B.Voc from Pharmacology & Pharmaceutics
GITAM University
Diploma from Certificate in Pharma Process Technology
Cherukupalli Junior College
Intermediate from M.P.C
Govt. High School, Kavur
S.S.C from S.S.C
Similar Profiles
Rishit BajpaiRishit Bajpai
Service delivery Ops specialist at Accenture Solutions Pvt. Ltd.Service delivery Ops specialist at Accenture Solutions Pvt. Ltd.
Pranshu SoniPranshu Soni
Application Development Analyst at Accenture Solutions Pvt. Ltd.Application Development Analyst at Accenture Solutions Pvt. Ltd.
Sneha NamaSneha Nama
Advanced App Engineering Analyst at Accenture Solutions Pvt. Ltd.Advanced App Engineering Analyst at Accenture Solutions Pvt. Ltd.
AINSTEN NADARAINSTEN NADAR
Service Delivery Ops Associate Manager, RTR (GBS - Revenue) at Accenture Solutions Pvt. Ltd.Service Delivery Ops Associate Manager, RTR (GBS - Revenue) at Accenture Solutions Pvt. Ltd.
Nithin SaraNithin Sara
Sr. Product Engineer at TECHMAHINDRA LTDSr. Product Engineer at TECHMAHINDRA LTD