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Rishiraj DRA

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24 views3 pages

Rishiraj DRA

Uploaded by

yiyaver917
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Rishiraj Saxena rishirajsaxena7@gmail.

com
8770301236
02/07/1996
shyam vihar colony, Morena, Madhya
Pradesh

Objective Seeking employment with a company where I can use my talents and skills to grow the
company.

Experience Asmoh laboratories Ltd


Sr. Executive DRA OCTOBER 2023 - TILL NOW

(1)Preparation and Compilation of dossier (Common Technical Document & Country Specific)
(2) Coordination With QA & QC department for Quality Document
(3) Preparation and Review of Quality Document and received from plant
(AMV,BMR,BPR,PVP,PVR, Stability Study Data and others documents)
(4) preparation & Review Summer of product characteristics
(5) Artwork checking as per country guidelines.
(6) Preparation of any type documents quality related and DRA documents.

XL laboratories PVT LTD (EU certified)


Sr. officers QA & DRA condonation department OCTOBER 2022 - OCTOBER 2023

1) Prepared, Review and correction BMR , BPR, SOPs, protocols as per


guidelines as regulatory requirements.
2)Preparation and Compilation of dossier for EU
3) Compliance of quality system - to review and taken of Change Control,
Deviation, Incidences and OOS.
4) Processes Validation prepared protocol, reports & related investigation.
5) Prepared, Review and approval of protocols, reports Stability and
compliance of stability Data.
6) Documents, Samples & Department related Activity.
7) MRM, Self Inspection, Vendor Qualifications & Market Compliant.
8) Prepared all trend (like change control, deviation, incident & OOS)
9) Documents & Department related Activity.

Aculife Healthcare Private Limited (Ahmedabad, Gujarat)


QA Officer QA AUGUST 2021 - OCTOBER 2022

1)Prepared, Review and correction BMR , BPR, SOPs, protocols as per


guidelines as regulatory requirements.
2) Compliance of quality system - to review and taken of Change
Control, Deviation, Incidences, OOS and CAPAs.
3)Processes Validation prepared protocol, reports &
related investigation.
4)Prepared, Review and approval of protocols, reports Stability and
compliance of stability Data.
5)Prepared and review Cleaning Validation protocol and reports.
6) Review and correction PDR, BOM, MFR, Technology
Transfer and Qualifications.
7) Review and Preparation the compliance of Analytical Method
Validation, Verification, Transfer Technology activity such as
protocols, reports and raw data.
8) Internal Audit and compliances as per GMP & GLP. Trainings
as per requirement and SOPs.
9) Instrument & Equipment Qualification DQ, IQ, OQ & PQ.
10) To review Standard Test Procedures, Specifications,Stability
data review and MOA as per
11) Documents, Samples & Department related Activity.

Polestar Power Industry (Pharma Division) Part of IndocoRemedies


Baddi H.P
QA Officer QA JANUARY 2019 - AUGUST 2021

1)BMR , BPR, SOPs & Stability Preparation and review as per


guidelines as regulatory requirements
2) Change control, Deviation & CAPAs.
3)Processes Validation protocol, Report, challenge test &
related investigation.
4).Review and prepared protocols, reports Stability and
compliance of stability Data
5)Preparation and review Cleaning Validation.

6) Prepared and correction PDR, BOM, MFR & Technology Transfer

7) Preparation & review STP, specifications as per requirements.

8)Vendar Qualifications, Equipment Qualifications(DQ,IQ,OQ & PQ).

9) Documents issued.

Education Jai Balaji High School Morena (M.P) 2013


10th - 45%

Jai Durge H. S. School Morena (M.P) 2015


12th - 55%

ITM UNIVERSITY GWALIOR (M.P) 2019


B. Pharma - 5.9 CGPA

ITM University Gwalior (M.P) 2022


M.Pharma - 6.5 CGPA

Audit face EU-GMP - Europe


ANVISA - Brazil
TGA - Australia
WHO

Skills SOFT SKILL TRAINING: Communication skill, personal development COMPUTER SKILLS:
Have some basic skill about. MS Office. AmpleLogic Change Control, Deviation, CAPA, OOS,
OOT. SAP Calibration Details, Issued Documents, BOM, All activities SAP

Language Hindi English

Achievements 2nd Prize Poster Presentation,


& Awards HIV (Human immunodeficiency virus),
ITM UNIVERSITY GWALIOR (M.P)

Activities 2nd Prize Poster Presentation,


HIV (Human immunodeficiency virus),
ITM UNIVERSITY GWALIOR (M.P)

Strength • I’m good at creating positivity in the workplace.


• I’m good at time management.
• I’m good at multi-tasking.
• I’m good at communication,

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