Quality Assurance Project Management
Resume:
Kandarpkumar A. Patel [B.Pharm, M.S. (USA)]
OBJECTIVE
To associate myself with an organization that provides me an opportunity to show my skills and ability, improve my knowledge and to be a part of the team that works dynamically towards the growth of the organization in improving the quality of product.
AREA OF EXPERTISE
Preparation and execution of HVAC, Equipment Qualification, Process Validation, PLC Computer system validation, cleaning validation documents.
Actively participated to set up New expansion facility, pilot plant facility and also lead the team for setting up the new formulation plant in Algeria.
Proficient in cGMP maintenance in Compliance and Market Complaint Handling, Vendor Management, Preparation of BMR’s, SOP’s, handling of deviations and change controls.
Good communication and team management skills
Qualified the equipment for new expansion facility.
Prepared Dossiers for Semi regulatory market (ACTD) and ROW market.
Well familiar with MS Word, MS Excel and MS PowerPoint.
Organizational abilities; possess a flexible & oriented attitude.
PHARMACEUTICAL EXPERIENCE (6Years)
1)ALEMBIC PHARMACEUTICAL, Baroda. Since June 2012- till the date
Position: Sr. Executive QA .
2)CENTURION LABORATORIES, Baroda. Since October 2010- June 2012
Position: RA/ QA Officer
3)LINCOLN PHARMACEUTICAL, Ahmedabad. Since April 2010- Oct 2010
Position: QA Officer
4)ACRON PHARMACEUTICAL, Ahmedabad. Since Dec 2005- Jan 2006
Position: Internship
CAREER HIGHIGHTS
1)Organization: ALEMBIC PHARMACUTICALS, VADODARA (Gujarat).
Designation: Q.A. Sr. Executive.
Duration: Working since June 2012 to till date.
Work Description:
Preparation and Revision of Standard operating procedures related to validation.
Preparation, execution and review of qualification document related to HVAC, Compressed Air, computer system validation, water system.
Preparation and review of process validation and cleaning validation.
Leading the qualification and validation team.
Qualified AHU’s, Water system, and Equipments.
Actively participated in set up of New Expansion plant as well as Pilot plant facility for Equipment qualification, AHU qualification, Facility qualification etc.
Travelled to Algeria plant for plant set up (Alembic Mami, Constantine) all documentation and qualification activities etc.
Preparation of QA SOP’s.
QMS related activities (Deviation, Change Control, Issuance of BMR etc.
To give audit compliance related to Qualification and Validation.
Initiation of change controls.
Performed Audit for production, Engineering and QC department related to safety.
Review and Issuance of BMR/BPR as second work responsibility.
As approved trainer training to functional team members & QA procedures.
Documentation preparation for new facility related activity.
Coordination with different area for execution of qualification and validation activities.
2)Organization: CENTURION LABORATORIES PVT. LTD, VADODARA (Gujarat).
Designation: Regulatory Affairs/Quality Assurance Officer
Duration: Working since October 2010 to till date.
Work Description:
Working as a Quality Assurance/Regulatory Affairs Officer.
Maintained Product Dossier, Process Validation Protocol, Retrospective validation and Product master files.
Preparing Process validation and Qualification Protocols.
Prepared/Assisted for preparation of SOP’s for QA
Work involves preparation of ACTD Dossiers for countries like Kenya, Algeria, Philippines, Vietnam and Thailand etc.
Well conversant with Export Dossier for ROW market like African Countries (Nigeria, Guinee– Conakry, Ghana), CIS countries like Ukraine as well as Registration as per Country Guidelines and other Documents required for Registration of the Pharmaceutical Product for different Tenders.
Coordinating through interaction with [Research and Development Dept., Manufacturing Dept., Quality Control Dept., Quality Assurance Dept., Packing dept., and Medical Dept.]
Solving queries raised by Parties / Buyers.
Well conversant for Legalization Process for Product registration like preparing Certificate of Pharmaceutical Product (COPP).
Have knowledge in application of Product Permission, COPP, and Free Sale Certificate.
3)Organization: LINCOLN PHARMACEUTICAL, Gandhinagar (Gujarat).
Designation: Quality Assurance Officer
Duration: Working since April 2010 to October 2010.
Work Description: Working as a Quality Assurance/Regulatory Affairs Officer.
Maintained Product Dossier, Process Validation Protocol, Retrospective validation and Product master files.
Preparing Process validation Protocols.
4)Organization: ACRON PHARMACEUTICAL, Ahmedabad (Gujarat).
Designation: Internship
Duration: Working since Dec 2005- Jan 2006.
JOB RESPONSIBLITIES
Prepared Process Validation, Qualification of AHU, Equipment, Computer system validation and Cleaning Validation protocols.
Prepared SOP’s for QA and Production department.
Handled IPQC in tablet production department.
Preparing Dossiers for ROW & ACTD countries like Kenya, Vietnam, Philippines, Ukraine, Nigeria etc.
Prepared Product Permission application.
ACADEMIC PROJECTS
Process Validation
The whole project was based on Validation of Transdermal products which included Master Validation Plan, Qualification, Protocol, and Documentation.
Project Management
This project was to make the WBS, Gantt chart, PERT, Critical Path, Balancing Resources, labor
Requirements from the given data.
EDUCATION BACKGROUND
S.S.C. – Nutan English School
H.S.C – New Saurabh Higher Secondary School
Bachelor in Pharmacy Dayanada Sagar College of Pharmacy, Bangalore - INDIA
M.S in Pharmaceutical Manufacturing – Stevens Institute of Technology, Hoboken, NJ, USA
COMPUTER SKILLS
Operating Systems
Windows MS/95/98/2000/Xp/Vista, Surfing.
Pharma Software
Pharmasuite
SEMINARS ATTENDED
Seminar on GLP, CTD and eCTD dossier, Patent- Ahmedabad.
DIALECT SPOKEN
English, Hindi, Gujarati
STRENGTHS
Flexible
Dedicated
Easily adapt to any working environment
Excellent communication skill
Hard working and very confident person.
PERSONAL PROFILE
Name : Kandarpkumar Arunbhai Patel
Date Of Birth : 06/08/1983
Marital Status : Married
Nationality : Indian
Hobbies : Playing Games
Present Address : B/54 Marutidham Society
TP-13, Channi Jakat Naka
Baroda Gujarat, India.
DECLARATION
I do here by confirm that the information given in this form is true to do the best of my knowledge and belief.
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