Quality Assurance Manager

MR. SANTOSH K. PANDA

***, ****** ****** ***** ******, J.B. Nagar, Andheri (E), Mumbai-400059

Mobile: +91-808*******, E-Mail: ************@*****.***

PROFESSIONAL SKILLS:

Compiled & reviewed the regulatory submission for Pharmaceutical formulations for different countries including ASEAN & African (Semi regulated/Emerging) countries.

Compiling, reviewing, and processing regulatory submissions, including Product Dossiers in ICH CTD format Modules for submission to the Regulatory Agencies of the various countries.

Experienced in resolving the queries as requested by the Customers and Regulatory Agencies.

Critical review & Compilation of technical documents, Artworks, Summary of Product Characteristics and Patient Information Leaflets.

Independently handling of all dossiers as per country requirements.

Co- ordination with R & D, QA / QC for preparation of dossiers

Literature search from various Websites and Journals

Good communication & analytical & presentation skills

PROFESSIONAL EXPERIENCE:

Working as Regulatory Affairs Executive in Gufic Stridden Biopharma Pvt. Ltd., Mumbai from July 2011 till date.

Worked as Quality Assurance Officer in SUN PHARMA INDUSTRIES LIMITED (A WHO, MCC, NAFDAC,UKRAINE & ANVISA Approved plant manufacturing solid dosage forms like tablets, capsules, pellets etc.) from August 2009 to June 2011

Worked as Junior Production Officer in RUSAN PHARMA LIMITED, Gujarat (A MHRA & MCC Approved plant manufacturing tablets, capsules, ointments, creams & Injectables) from August 2006 to July 2007.

JOB RESPONSIBILITIES:

Preparing Product Dossiers Country specific for Oral Dosage Forms (Tablets, Capsules and Parenterals (Antibiotics, Beta blockers, Proton Pump Inhibitors, Lyophilized Injections) for different countries including ASEAN/African Countries and ROW countries.

Review of R&D, QC,QA & Production documents effectively.

Process Validation & Analytical Method Validation of Product Manufacturing.

Prepared Pharmacological information for various molecules for compilation of dossiers.

Maintenance of Dossiers and Regulatory documents.

Coordinating with FDA of Maharashtra & Gujarat for Manufacturing License, GMP Certificate, Free Sale Certificate & Certificate of Pharmaceutical Product (COPP).

Compilation and Development of Labels / Package Inserts as per country specific requirements.

SPECIALTIES:

Comprehensive knowledge and experience in Regulatory Affairs submissions in Pharmaceutical companies for ASEAN countries/AFRICAN countries and Row markets.

Having Knowledge and awareness of ICH, DCGI and Asian countries guidelines.

BMR & BPR review & Trend Analysis

Preparation of APR & PQR

Change Control/PMF Review-Impact Analysis/CAR/CAPA

Event, OOS/Incidence & Knowledge of Market Complaint investigation

Process Validation/Cleaning Validation/Qualification/Preventive Maintenance/Calibration documents

Qualification/Validation/Re-qualification/Revalidation activity as per schedule

Product Release (domestic & export) by Review of all Documentation relating to the Manufacturing, Packaging & analysis report and market dispatch.

DRUG DISCOVERY & DEVELOPMENT PROJECTS HANDLED :

Presented a Poster in 59th Indian Pharmaceutical Congress 2008, Delhi on “Design, Synthesis, Molecular Docking and Pharmacological Screening of Novel Anti-inflammatory Agents”

Paper accepted by “Journal of Enzyme Inhibition and Medicinal Chemistry” entitled “Design, Synthesis and Evaluation of Anti-inflammatory, Analgesic, Ulcerogenicity and Nitric oxide releasing studies of Novel Indomethacin analogues as Nonulcerogenic Derivatives”. Manuscript No:-GENZ-2009-0175

Paper communicated to “Tetrahedron” entitled “Design, Synthesis and Pharmacological screening of 2-arylimino-5-arylidene-4-thiazolidinones rings”. Manuscript No:- TET-D-09-01165

Paper communicated to “Journal of Brazilian chemical Society” entitled “Design, Synthesis & Biological evaluation of some mannich bases as antimycobacterial agents” Temp. Manuscript No: - tmp_7285 tmp.

Paper communicated to “Journal of Brazilian chemical Society” entitled “Novel hydrazones of 4-(4-morpholino) benzohydrazide: 2D- QSAR, synthesis and preliminary evaluation as antimicrobial agents”

ACADEMIC ACHIEVEMENTS

Education and Credentials

M. Pharm. [Pharmaceutical Chemistry] with Distinction, from University of Pune [2009][University Topper]

Key Achievements

University Topper from Pune University in the year 2008-09.

Qualified AICTE Research Fellowship (GATE)-2007-08.

Qualified AICTE Research Fellowship (GATE)-2008-09.

Third position in 2005 and Fourth position in 2006 in Utkal University

First prize in Quiz Competition held by The Indian Pharmaceutical Association, BBSR, Orissa branch (2003-2004,2005-2006)

Computer Proficiency with thorough knowledge of Internet and mailing.

PUBLICATIONS

Research Papers / Review Articles:

International Publications: 03 National Publication: 02 National Poster Presentations: 02

EXTRA CURRICULAR SPARKS:

Receiving many honors and awards for writing & G.K. during studies (poems & articles & short stories published in newspapers, magazines & online) Special Interest: Literature & Writing.

PERSONAL DOSSIER:

Date of Birth: June 13, 1981 Languages Known: English, Hindi, Marathi and Oriya Marital Status: Bachelor Address: Jagatsinghpur, Odisha, India-754103

REFERENCES:

1. Mr.Dilip Ghosh

Director,

Gufic Stridden Biopharma Private Limited

Email: **********@********.***

2. Mr. Debendra Panda

Sr. Executive, F&D,

Pfizer, Mumbai.

Email: *************@*****.***

3. Mr. Minaketan Routray

Sr. Executive, F&D,

SPIL, Mumbai.

Email: *********.*******@*********.***

4. Mrs Alka Singhane

Asst. Manager, Regulatory Affairs,

Gufic Biosciences Limited, Mumbai.

Email: ******@********.***

Date:

Place: Mumbai Mr. Santosh K. Panda

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