Niranjan Patra

Niranjan Patra Email and Phone Number

Senior Manager @ AUROBINDO PHARMA LTD
Hyderabad, IN
Niranjan Patra's Location
Hyderabad, Telangana, India, India
Niranjan Patra's Contact Details

Niranjan Patra work email

Niranjan Patra personal email

n/a
About Niranjan Patra

13 + years of experience pharmaceutical industry. Risk based approach to validate a computerized system (CSV/CSA Approach). Compliance, URS, GXP Assessment, Quality Risk Assessment, ER-ES Assessment,Audit trail revie. Validation of analytical and process related software. Deliverables: URS,SLIA, DQ, FAT, QRA,PSQP, IQ, OQ & PQ,RTM 21 CFR part 11 compliance, EU Annexure 11 regulation, Data integrity, GAMP 5,Data backup and Restoration, Handling of IT Ticketing, preventive maintenance & windows control verification, periodic review of computerized system,Investigation, spoke for external audit, conduct internal audit, Response and compliance on external observations, Computer system validation as per GAMP 5, Change control

Niranjan Patra's Current Company Details
AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd

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Senior Manager
Hyderabad, IN
Niranjan Patra Work Experience Details
  • Aurobindo Pharma Ltd
    Senior Manager
    Aurobindo Pharma Ltd
    Hyderabad, In
    View
  • Aurobindo Pharma Ltd
    Senior Manager
    Aurobindo Pharma Ltd Nov 2023 - Present
    India
    Global CSV and Compliance
    View
  • Aurobindo Pharma Ltd
    Manager
    Aurobindo Pharma Ltd Jun 2022 - Present
    India
    View
  • Dr. Reddy'S Laboratories
    Subject Matter Expert
    Dr. Reddy'S Laboratories Jun 2015 - Present
    India
    CSV & ITQA Specialist ( Risk based life cycle approach to validate a computerized system, V Model) , GAMP-5, 21 CFR part 11, EU Annexure 11 , Quantitative Risk Assessment, Audit Trail Review, Windows control verification, Periodic verification of validated computerized system, Backup and Restoration Testing, User Management, Verification of privileges & security policy, Internal Audit, Handling Regulatory Audit, Windows control verification, Review and closure of GXP & Non-GXP Tickets, Handling… Show more CSV & ITQA Specialist ( Risk based life cycle approach to validate a computerized system, V Model) , GAMP-5, 21 CFR part 11, EU Annexure 11 , Quantitative Risk Assessment, Audit Trail Review, Windows control verification, Periodic verification of validated computerized system, Backup and Restoration Testing, User Management, Verification of privileges & security policy, Internal Audit, Handling Regulatory Audit, Windows control verification, Review and closure of GXP & Non-GXP Tickets, Handling of incident and involved in investigation, instrument/equipment Qualification Show less
    View
  • Dr. Reddy'S Laboratories
    Specialist
    Dr. Reddy'S Laboratories Jun 2015 - Jan 2022
    Hyderabad, Telangana, India
    ITQA
    View
  • Cipla
    Team Leader
    Cipla May 2013 - May 2015
    Indore Area, India
    Qualification and compliance over QC instrument & equipment
    View

Niranjan Patra Education Details

Frequently Asked Questions about Niranjan Patra

What company does Niranjan Patra work for?

Niranjan Patra works for Aurobindo Pharma Ltd

What is Niranjan Patra's role at the current company?

Niranjan Patra's current role is Senior Manager.

What is Niranjan Patra's email address?

Niranjan Patra's email address is ni****@****dys.com

What schools did Niranjan Patra attend?

Niranjan Patra attended Berhampur University.

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