Quality Assurance Plant

GANDHI RIKINKUMAR SURYAKANT

Mobile: 090********; 026******** E-Mail: rikinpharma@gmailcom, *****.******@*******.**.**

Seeking assignments in the domain of QUALITY ASSURANCE / CORPORATE QUALITY ASSURANCE with a growth oriented organisation of repute

Location Preference: Gujarat, Bangalore, Mumbai and Hyderabad

AN OVERVIEW

Working as a Senior EXECUTIVE in Quality Assurance of Quality Division at Alembic Pharmaceutical Limited., Panlave, Vadodara, (certified US-FDA, UK-MHRA, cGMP, TGA, ANVISA) is manufacturing Tablet & capsule since DEC.2009.

Responsible for implementation and further support for QM Module of SAP ECC 6.0 version at Alembic Pharmaceuticals LTD

Audit Exposure: External & Internal audit of various regulatory authorities like US-FDA, UK-MHRA, ANVISA – BRAZIL, Pfizer, TEVA, Ranbaxy, Bluefish, Ratiopharm etc

ANVISA BRAZIL Audit: For Formulation (Tablet & Capsule) – May 16th to 20th –2011 and play key role for explaining the In process Analysis, Batch Manufacturing & Packing Records, And Process validation to

Name of Auditor: Ms. Maria & Ms. Erieldes

USFDA Audit: For Formulation (Tablet & Capsule) – May 11th to 16th –2010

Name of Auditor :Dr. Muralidhara Gavini & Pankaj Amin

MHRA Audit: For Formulation (Tablet & Capsule) – Apr. 26nd to 28th –2010

Name of Auditor : Mark birse & Michal woothall

Impressive record with 1 year and 4 months experience in Pharmaceutical production operation of Tablets & Capsules, Hamax Pharmaceuticals, Vadodara (Jan 2006 to April 2007)

Pursue M.Pharma. & secured first rank to Post graduate department of SCS College of Pharmacy, Rajiv Gandhi University of Health Science, Karnataka.

Completing dissertation: “A Study on Drug – Drug Interaction of Anti – epileptic & oral Anti-diabetic drugs” under the guidance of Dr. S. Ramachandra Setty.

Awarded the Eight Rank in Pharmacokinetics and Therapeutic Drug Monitoring with 70.00% of marks in Final year B.Pharm at Rajiv Gandhi University of Health Sciences, Bangalore.

Well versed with “Basic Concept of Pharmacological Screening, Pharmacology & Human Anatomy”.

Adaptable and a quick learner; possess skills to work under pressure.

Instrument Exposure: ERWEKA tablets Tester, Dr Schleuniger Tablet Tester, Mettler Analytical Balance, Dissolution Test Apparatus, HPLC, Double Beam U.V. Spectrophotometer; Colorimeter and Autoanalyser.

Proficiency at grasping new technical concepts quickly & utilizing it in a productive manner.

Believe in continuous learning and an innovative approach.

Possess good communication skill, systematic approach and ability to work effectively in fast paced environments.

Current Job Responsibility

o Handling of Process Validation.

o Handling of Cleaning Validation.

o Handling of Hold time Study.

o Handling of Transportation Study.

o Handling of Qualification.

o QM Module Representative of Material Master Cell for SAP masters Creation.

o Handling and resolve SAP Issue from All plant of Alembic Pharmaceutical LTD.

o Handling and Maintain SAP Qualification for All plant of Alembic Pharmaceutical LTD.

o Perform monthly Audit & Report for SAP system for all plant of Alembic Pharmaceutical LTD.

Role during Implementation of SAP ECC 6.0

Implemented QM Module for 3 Plant of API and 1 Plant of Domestic Formulation & 1 Plant of International Formulation of Alembic Pharmaceuticals Limited.

Also provide online solution for error created during execution of any QM module process in Manufacturing.

Prepare and execute Installation Qualification, Operation Qualification, Validation Protocol and Report for SAP ECC 6.0 and Performance Qualification of SAP ECC 6.0 is under Process.

Designed, Implemented SAP ECC 6.0 for different Plant and for verity of Condition and Conducted End User Training on

o Quality Module in Material Master

o Preparation of Vendor Master

o Sampling Procedure

o Catalog

o Preparation of Inspection Plan

o In process Inspection Plan

o Acceptance Quality Check (AQL)

o Result Recording

o Out of Trend

o Stability Study schedule and Auto Lot Creation

o Hold time Study Schedule and Auto Lot Creation

o Auto / Manual Purchase Requisition

o Water Analysis Scheduling and Auto Lot Creation

o Calibration Scheduling and Auto Lot Creation

o Notification for

Deviation

Change Control

Incident

Market Complaint with FMEA scheme

Stability

Maintenance

Batch Failure

Non complies

o Document Management System (DMS)

o BMR / BPR / BCR / Test Data Sheet (QC) Printing with Batch Detail From SAP through DMS

o Annual Product Review (APR) from SAP

o Label Printing

Regulatory Related Activity & support to other area

Faced US-FDA, UK-MHRA, ANVISA – BRAZIL, Pfizer, TEVA, Ranbaxy, Bluefish, Ratiopharm etc successfully.

Harmonized Quality System at all Plant of Alembic Pharmaceuticals LTD.

Handling of Deviation, Change Control, Incident and CAPA.

Preparation and Review of Annual Product Review

IPQC in manufacturing area for solid oral dosage form.

Regular monitoring of GMP activities in manufacturing area.

SOP management and implementation to the respective areas.

Instrument calibration and verification.

Co-ordination with different departments for smooth functioning.

Line Clearance of various Machineries engaged in Manufacturing and Packaging department.

Acceptance Quality Level Checked.

BMR and BPR Review.

Batch Record Issuance.

Review of Art work for US, Europe and other Exports

Review of market complaints and resounds to them.

ACADEMIC CREDENTIALS

2009 Masters in Pharmacy - Pharmacology from SCS College of Pharmacy, Rajiv Gandhi University of Health Science, Karnataka. Secured – 77.07%

2005 Bachelor of Pharmacy from SCS College of Pharmacy, Rajiv Gandhi University of Health Science, Karnataka. Secured 69.41%

2000 Higher Secondary Certificate from Shreyash Vidyalaya, Gujarat Education Board. Secured 50.92%

1998 Senior Secondary Certificate from Shree Por Vidyalaya, Gujarat Education Board. Secured 74.86%

IT FORTE: Conversant with Windows, MS Office, Web Designing and Internet Applications

“Design and develop the website www.scscop.org”

DISSERTATION: “A Study on Drug – Drug interaction of Anti – epileptic & oral Anti – diabetic drugs”

CONFERENCES ATTENDED

Presented a poster at 61th IPC held at Nirma University, Ahmadabad: 2009 entitled 'A Study on Drug-Drug Interaction of Carbamazepine And Glibenclamide'

Presented a poster at 61th IPC held at Nirma University, Ahmadabad: 2009 entitled 'A Study on Drug-Drug Interaction of Carbamazepine And Rosiglitazone'

Participated and Presented Poster entitled: Antioxidant & Hepatoprotective Activity of Peltophorum pterocarpum in 59th Indian Pharmaceutical Congress, 2007 held at Banaras Hindu University, Varanasi.

All India Council for Technical Education, New Delhi, College of Pharmacy, Hubli, Karnataka

Seminar on “Molecular Biology” by Dr. P.D. Gupta, Shree Siddaganga College of Pharmacy, Tumkur, Karnataka

INDUSTRIAL EXPOSURE

API Plant, Alembic Pharmaceutical LTD, Panelav

Domestic Formulation. Alembic Pharmaceuticals LTD, Baddi

Regulatory Formulation, Alembic Pharmaceutical LTD, Panelav

Octopus Pharma Ltd., Hyderabad

Rays Health Care Pvt. Ltd., Hyderabad

Pangea Pharma Ltd., Hyderabad

PERSONAL VITAE

Logical thinking & Positive attitude.

Effective leadership quality.

Maintaining good interpersonal relationships & active involvement in any sort of groups.

PERSONAL VITAE

Date of Birth : 08th October, 1983

Residential Address : Near Main Gate; At & Post: Por; Ta & Dist: Vadodara; Gujarat; 391243

Linguistic Abilities : English, Gujarati & Hindi

Relationship : Married

DECLARATION

I hereby declare that the above-mentioned information’s are authentic and true to the best of my knowledge.

RIKIN GANDHI M.Pharm

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