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Data Pharmacy

Location:
Mumbai, Maharashtra, India
Posted:
October 15, 2020

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+919********* Page * of * adgzr0@r.postjobfree.com

CURRICULUM VITAE

Raghunath Dilip Chidrawar (M. Pharma)

PRESENT ADDRESS

Mr. Raghunath Dilip Chidrawar

R/o. 101, Elite K Lakeshore Green,

Near Taloja bypass, khoni

Dombivali- 424204

CAREER OBJECTIVE

To seek a position where I can utilize my technical, analytical and communication skills in an industry that offers intellectual and professional growth, while being resourceful, innovative and flexible. WORK EXPERIENCE

I am working with Mazars LLP, Mumbai, From 27/08/2020 to till date as CSV auditor.

I have worked with Inventia Healthcare ltd, Mumbai from 04/11/2019 to 24/08/2020 as CSV Executive.

I have worked with Cognizant Technological solution, Mumbai from 18/08/2014 to 18/10/2019 as Programmer Analyst.

I have worked with JB Chemicals and Pharmaceutical Thane from 18/07/2013 to 20/06/2014 as R&D officer.

I have worked with BDH Industries Ltd. Mumbai from 16/5/2012 to 16/07/2013 as Regulatory Affairs officer.

I have worked with Anazeal Analytical & Research Center, Mumbai from 27/9/2011 to 30/4/2012 as Trainee Chemist.

Key role

Computer System Validation (CSV)

• Worked as SME for CTMS IMPACT, STARLIMS, MES system during CSV documentation.

• Well versed with FDA regulations, GAMP 5 standards, EU ANNEX 11, 21 CFR Part 11, GxP Compliance.

• Involved in documentation of computerized system validation deliverable e.g. URS, FRS, Vendor assessment, Risk assessment, GxP assessment, Validation Plan, Qualification Protocol, Requirement Traceability matrix, validation summary report, System Description.

• Worked on end to end Computer system validation, Risk assessment, Test management and gap analysis activity.

• Reviewed Executed validation protocols test cases and adhered to compliance and GxP guidelines.

• Reviewed and modified Standard Operating Procedures for QA and implemented CAPA for various issue. Clinical Data Management

• Involved in functional testing of clinical Study with the use of HPALM tool during study setup.

• Written and executed test script for Functional Testing of clinical study.

• Well versed with oncological study setup, conduct and closeout activities.

• Reviewed clinical data on RAVE database using excel formula and macros,

• Reviewed of Lab data, safety data reconciliation and External data reconciliation (Discrepancy Management and Query Management).

Regulatory Affair

• Submission of registration dossiers to DRA in compliance with the country’s guidelines.

• Prepared Leaflets – by reviewing the clinical data for writing comprehensible, user-friendly, clear product information leaflets and labels.

• Involved in procedure for approval of COPP and WHO GMP Certification from CDSCO India.

• Monitored and set the timelines for license verification and renewal approvals.

• Prepared dossiers in eCTD, CTD format processed and track regulatory documents. Research and Development

• Prepared of RMS, FPS, and Stability data planning.

• Worked on Stability, OOS, User management, Column Management, Raw material inventory modules of LIMS Application.

• Worked on analytical method development and Validation for Assay, Dissolution by UV with the help of HPLC.

• Performed stability studies as per ICH and WHO guideline. AWARDS AND RECOGNITION

• Awarded Lean with Basic Six Sigma certificate for completion of Data Quality and Compliance project from cognizant.

• Cognizant management rewarded 4 times for quality work and creative work in projects.

+919********* Page 2 of 2 adgzr0@r.postjobfree.com

COMPUTER PROFICIENCY

• MS-CIT (92%).

• Operating Systems: Windows-98, 2000, Windows XP & Windows Vista.

• Conversant with Microsoft office (MS Word, MS Excel, & Power point).

• Software handled LC Solution, EZ crome Elite, Perkin Elmer for HPLC and LCMS. PRESENTATIONS

• Presented a Poster in 60th IPC held at Delhi On title “EFFECT OF SR-105 ON SODIUM NITRITE INDUCED HEMIC HYPOXIA”.

• Presented poster at Loni “MOLECULAR MODELING AND DESIGN OF DOPAMINE D2 PARTIAL AGONIST”.

• Published Review on “UPLC:AN EMINANT, FAST AND SENSITIVE METHOD OVER HPLC”, ijapronline, Vol 01,01; 2011,01-12

CONFERANCES AND SEMINAR ATTENDED

• Attended 60th IPC, held at Delhi.

• Participated in workshop on “RECENT ADVANCES IN HERBAL DRUG EVALUATION”, held at Loni.

• Attended Seminar on “INNOVATION OF MATERIAL AND SYNTHESIS”, held at Nanded.

• Attended Seminar on “SOCIAL CONTEST OF SOFT SKILL AND PERSONALITY DEVELOPMENT”, held at Nanded.

• Attended Conference on ‘INVESTOR MEETS’, held at Nanded EDUCATIONAL QUALIFICATION

Degree/ Examination Institute /Organization Board/ University Year of Passing

M. Pharm. (Pharmaceutical Chemistry)

School of Pharmacy (University

Dept.) Nanded

SRTM University,

Nanded

2011

B. Pharm.

Shivlingeshwar College of

Pharmacy, Hasegaon, Latur

SRTM University,

Nanded.

2009

D. Pharm.

Ishwar Deshmukh Institute of

Pharmacy Digras, Yawatmal

M.S.B.T.E. Mumbai 2005

PERSONAL DETAILS

Date of Birth 27th Jan 1986

Gender Male

Marital status Married

Languages known English, Hindi, Marathi

Contact no +919*********

E-mail Address adgzr0@r.postjobfree.com

Nationality Indian

DECLARATION

I hereby declare that the above written particulars are true to the best of my knowledge and belief. Date:

Place: Mumbai

Raghunath D. Chidrawar

~~~ Thank You for Your Time ~~~



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