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Assistant Manager Quality

Vadodara, Gujarat, India
June 25, 2019

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B-147, L.G.Park-1, Cell no: 999-***-****

B/H Vrajdham Temple, Email: Manjalpur.



Seeking for a dynamic and challenging position where I can effectively utilize my expertise in Pharmaceutical Sciences and make a positive contribution to the organization. EDUCATIONAL QUALIFICATION:

Course University / Board

Year of


Class Percentage


4th sem

Gujarat Technological


Jul-2012 Distinction 8.0 out of 10 SPI


4th year


Amravati University

Jun-2010 First 63.33%


2nd year

Karnataka Board Sep-2006 First 61.30%

H.S.C G.. S. E. B. Mar-2004 Second 50.31%

S.S.C G. S. E. B. Mar-2002 Distinction 78.14%


7 Years of Experience in Quality Assurance Department in vigorous below listed key quality functions but not limited to...

Compliance Vendor Qualification

QMS Equipment/Facility Qualification

Computer System Validation Process/Cleaning Validation QA-RA IPQA

Year DESCRIPTION COMPANY Reporting Hierarchy

Feb-2017 to


Sr. Associate QA

LIVA Pharmaceuticals Ltd.

(Group of Zydus Cadila)

Ms. Seema Mehta

QA Head

Dec – 2015 to


QA Executive

Sanofi India Ltd.

(French MNC Company)

Ankleshwar, Gujarat

Mr. Chetan Trivedi

Associate Director Quality

Oct-2013 to


QA Officer

Sun Pharmaceutical Ind., Ltd.,

Karkhadi, Baroda.

Mr. Bhushan Rajput

DGM Quality

Dec-2012 to


QA Officer

Apothecon Pharmaceuticals Pvt. Ltd.

(Unit of Navinta LLC., USA.)

Dabhasa, Baroda

Mr. Vinod Patel

DGM Quality

May-2012 to


QA Officer

Osaka Pharmaceuticals Pvt. Ltd.

Sankarda, Baroda.

Ms. Meeta Panchal

QA Head

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‘Best Quality Performer’ rewarded by LIVA Management for providing extra qualitative and quantitative efforts in USFDA compliance among all the Zydun’s. Implemented SAP PM Module at LIVA Pharmaceuticals Ltd. (Group of Zydus Cadila) for Breakdown Maintenance, General Maintenance, Calibration and Preventive Maintenance and QMS Software (TrackWise and Documentum).

Implemented self-inspection and periodically verification of system (electronic and paper data) with respect to Data Integrity, Data Reliability and Audit Trail. Up gradation of Software : Continuously involved in up gradation of software by scrutiny monitored each GxP system as a software coordinator-compliance in charge and identify the areas for improvement in PLC/SCADA system as well as in QMS software with respect to 21 CFR part 11. Work appreciation reward by Mr. Chetan Trivedi, Associate Director Quality for providing an extra efforts by leading the QMS department of medical devise in Sanofi India Limited. Exhaustive support in Market Compliant Investigation, Deviation Investigation, CAPA and Training section.

Work appreciation reward by Mr. Bhushan Rajput, Quality Head as well as promoted within the short duration at SUN Pharma, Karkhadi for achieving time bound target and active support for implementation (Qualification/Training/SOP) of FMS (Documentum) and (QMS) Track Wise software as an one of the fraction of USFDA compliance. Vendor Assessment: Performed postal and in site inspection of vendor as a part of LCS (US consultant) compliance and clear the LRF.

SOP GAP Analysis ; In-depth review of key quality SOP’s, performed GAP analysis by verifying the actual practice, corporate quality policy and global regulatory standards as a part of LCS (US consultant) compliance and clear the LRF.

Effectiveness Verification of regulatory committed CAPA’s; Implemented Periodically verification system of implemented CAPA’s (mainly regulatory committed) i.e effectiveness check using the spot check method or audit method.

Work appreciation reward by Mr. Vinod Patel DGM-Quality at Apothecon Pharma for establish cleaning validation matrix of Drug product (Formulation) and Drug substance (API) using numerous regulatory/ corporate guideline.

SOP GAP Analysis; In-depth review of all departmental SOPs verify the actual practices verses procedure and rectifies the same.

Undergone extensive training/ dissertation work on “Equipment Qualification” at SUN Pharma, Halol from August -2011 to May-2012 under the immense guidance of respected Mr. Pratik Kamdar Manager-QA, Mr. Agam Patel Manager-QE and Mr.Sampad Bhattacharya Vice President of SPIL.

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Documentation :

Handling of various QMS documents such as Change Control, Deviation/Incident, CAPA, Risk Assessment, Market Complaints as an QA expert / QA reviewer. Periodically verify the effectiveness of CAPA for each failure or incident or observations or FDA committed CAPA to ensure that are being implemented effectively. Prepare, review trend analysis (Quarterly as well as Yearly) for Market Complaint / Deviation/Breakdown/ Batch record review / shop floor observation to develop robust quality system.

Act as a subject matter expert during internal or external audit for QMS documents and directly interact with an Auditor during the course of Audit. Active participation in the preparation of FDA Compliance Report., CQ compliance report, Internal Audit or Customer Audit compliance report. Coordinate with regulatory team / QP for any proposed changes or deviations which are impacted in regulatory submitted documents / products. Prepare, review various documents such as SOPs, APR/APQR, Cleaning Validation Protocol/Report, Process Validation Protocol/Report, Qualification Protocol/Report, Training Presentation, Global CAPA report etc.

Active participation in Vendor Audit, Vendor Qualification and Quality Agreement. Review various software qualification deliverables documents such as URS, SRS, RTM, IQ, OQ, PQ, risk assessment, LVPR and/or 21 CFR compliance report. Extensive knowledge of GAMP 5,21 CFR part 11,EU Annex 11, GLP, PIC /s guidelines Review Validation Protocol (Process/Cleaning/ Method) / BMR-BPR-ECR with respect to approved TTD (Technology Transfer Document) /PDR (Process Development Report)/ Lab Validation Data/ Analytical Specification/ STP/ Risk Assessment. Periodic review/verification of calibration/preventive maintenance schedule, archived documents, log books, control samples etc...

Monitor the issuance, distribution, review, archival and destruction procedure of GMP documents randomly.

Periodically perform inspection / GEMBA walk for data Integrity and reliability of documentation (electronic as well as manual).

Supplementary Skill :

In depth knowledge of various GxP software’s such as Document Management System

(FMS, GEOD +), QMS (Track Wise, Phenix), ERP-Metis, LIMS, SAP, Pharmacuite etc. Comprehensive knowledge of various regulatory guidelines for pharmaceuticals and their expectation.

Assist regulatory team during various fillings (Regulatory submission) by providing required documentary support.

Active participation in PLC/SCADA validation as per GAMP5. Page 4 of 4


USFDA at SUN Pharma and LIVA Pharma

LCS (Data integrity Consultant i.e Latchman Consultants) at SUN Pharma and LIVA Pharma EUGMP at Sanofi India Ltd.

Taiwan, Ukraine, WHO-GMP, TGA, GQA/ Corporate Audit at Sanofi India Ltd. Customer Audits at Osaka Pharma, Apothecon Pharma, SUN Pharma, Sanofi India Ltd. and LIVA Pharma.


Highly focused and determined individual.

Ability to work independently and also contribute as a team player. Diligent individual with a result oriented approach. Fast learner; ability to grasp new technologies with ease and implement its applications and add value to the organization.

Well informed and can put forth my ideas and arguments very lucidly and succinctly. Having excellent theoretical background with a good practical hand. PERSONAL DETAILS:

Father’s Name Dr. Dipakbhai R. Shah

Date of Birth 27th May 1987

Gender Male

Marital Status Married

Languages known English, Hindi, Gujarati, Marathi

Nationality Indian

Religion Hindu


I declare that the above information furnished by me is true to the best of my knowledge and I will present original documents whenever asked for. Date: With warm regards,

Place: Vadodara VIRAL D.SHAH

~~~ Thank You for Spending Your Valuable Time ~~~

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