CURRICULUM VITAE
PERSONAL DETAILS :
Name: Patel Hiren Lalbhai
Address: ***,*.* *****,******-4,
ghatlodia,ahmedabad-380061,gujarat,india
Phone No: +91-942*******
E-mail: t76hl3@r.postjobfree.com
Date of Birth: 09/08/1983
Sex: Male
Marital Status: Married
EDUCATIONAL QUALIFICATIONS :
Examination Passing Authority Year Of Passing Percentage Class
S.S.C.
GSEB
1998
83.00
Distinction
H.S.C.
GSEB
2000
73.69
Distinction
Bachelor of Pharmacy S.K. Patel College Of Pharmacy, Kherva 2004 67 First Class
Master of science
( G.M.P) Swinburne University of Technology 2009 72% Distinction
OBJECTIVE:
A detailed oriented technical profession with a strong history of superior performance, organization and analytical skills. To become a part and parcel of the growth of the company and profession. Ultimately to uphold the spirit of the profession of pharmacy. Expertise in tablet compression, coating and pellets coating and have a good analytical acumen.
To reach professional heights in the field of Quality Assurance through dedication and sincere efforts
PROFESSIONAL HISTORY:
• After completing my B.PHARM, I did industrial training at RESTECH PHARMACEAUTICALS LTD, CHANGODAR.
• In the year-mid 2004, I had joined ZYDUS CADILA HEALTHCARE LTD, AHMEDABAD, during this period, I become very much aware regarding cGMP and in process quality
• In Oct-2006, I had joined INTAS PHARMACEUTICALS LIMITED, AHMEDABAD.
• Nov-2007, I had joined TORRENT PHARMACEUTICALS LIMITED,INDRAD,KADI.
• Moreover I had faced many audits likes MCC, MHRA,TGA, ANVISA and US FDA inspection for metformin HCL tablet, atenolol tablet,methocarbamol tablet,gatifloxacin tablet and simvastatin tablet
JOB PROFILE:
• M.S (Good Manufacturing Practice)
Swinburne University of Technology, Hawthorn , Melbourne)
Duration : August-08 to November-2009
Completed course:-
1) International GMP & Quality assurance
2) GMP for manufacturing operation
3) Good Quality Control laboratory Practice
4) Chemical analysis of pharmaceutical
5) Contamination control
6) Validation Principle
7) GXP & Quality auditing practice
8) Process development for therapeutics: finished dosage form
9) Clinical trial Quality assurance management
10) Research skill
11) Computer system validation principle
12) Process development for therapeutics: Medical device
INDUSTRIAL BASED PROJECT:-Risk management principle in compliance auditing ( Under Guidance of –Steve Williams (Director of Seerpharma pty ltd)
And Sterilization validation strategies for therapeutic processes and product (Under Guidance of –Ece Smrdelj )
EXPOSURE : -
Developing and implementing the in-process quality systems for the production of solid dosage form and to ensure compliance with company internal procedures, policies, standards, and multiple regulatory bodies.
Designing a QMS, writing a Quality Manual, drafting necessary Standard Operating Procedures and assisted in addressing the non-conformances during an audit.
Develop VMP , IQ,OQ and PQ
To carry out Process Validation
Preparing prospective, con-current, retrospective data for product and finalize in process checks.
• Organization : TORRENT PHARMACEUTICALS LIMITED, INDRAD, KADI
Designation : Production Executive, Tablet manufacturing
Duration: November-2007 to July-2008
• Organization : INTAS PHARMACEUTICALS LIMITED,AHMEDABAD
Designation : PRODUCTION OFFICER, Tablet manufacturing
Duration: Octomber-2006 to November-2007
• Organization : ZYDUS CADILA HEALTHCARE LIMITED,AHMEDABAD
Designation : Chemist, Tablet manufacturing
Duration: September-2004 to September -2006
JOB PROFILE and RESPONSIBILITY:
• To plan and supervise in TABLET GRANULATION, TABLET COMPR ESSION , TABLET COATING area regarding in process quality and cGMP.
• I also monitoring in Tablet Compression, Coating and pellatization area (effective handling off fluid bed technology by pellets coating using GLATT machine-top spray & bottom spray).
• Trouble shooting in day to day problems in production.
• Finding the problems during tablet production& rectify it.
• Preparing retrospective data for product and finalize in process checks.
• New product manufacturing at production scale from pilot plant scale in co-ordination with F&D (Formulation and Development).
• Validation of new product at production scale.
• Helping document cell department for generation of documents like BMR,sops for new equipment/machine and shop floor activity.
• Review & control of Batch Manufacturing records and Batch packing Record, including exhibit batch records.
• Compliance of cGMP in manufacturing and packing areas
• Preparation and review of SOP
• In-Process Quality Control of Tablet and Capsule Manufacturing and Packing process.
• Calibration of IPQC Instruments
• New product manufacturing at production scale from pilot plant scale in co-ordination with F&D (Formulation and Development)
• Co –ordination of validation activities related to manufacturing, filling, packaging, quality control and site support system
• Co-ordination with R.M Store, P.M Store, Packing Dept., QA/QC dept., and maintenance department.
• Concern with general planning and supervising activity.
• Lead the release activities of intermediate manufacturing step for filling and packaging activities.
EXPOSURE:
• Elementary Knowledge of SAP R/3
I can operate MS-Office ,Window95, Window-XP,VISTA and 7, and other computer application.
REFERENCE:
1) Steve Williams
Director/Senior GMP Consultant
Seer pharma Pty Ltd
2) Ian Harding
Deputy Head of Bio Science
Swinburne University of technology
t76hl3@r.postjobfree.com
Ph no:-(006*-*********
Mobile no:- (006*-*********