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Hiren D. Shah
M.Pharm – Pharmaceutical Chemistry
E-302, Sahaj Sapience.,
Opp. APMC Market,
Behind Vishala Hotel,
Near Vaishali Township.
Vasna, Ahmedabad–380 055
Dist-Ahmedabad, Gujarat, INDIA
Contact no.: +91 9428386906
To assist group leader to ensure the regulatory compliance during API development
(including post approval activities) and ensure compliance of regulatory requirements
during life cycle and timely as well as qualitative DMF submission in global regulatory
To ensure compliance of regulatory requirements, in house quality system and ICH
guidelines in analytical development, MCD and API PP.
Currently working as SCIENTIST - II in Quality department (RA and CQA) of
Torrent Reserch Centre,Ahmedabad,
Previously worked as Research Associate-I in Piramal Discovery Solution Pvt.
Industrial Work Experience:
6.0 years rich experience in Pharmaceutical industry as well as CRO.
To review Feasibility,Optimization, and RC1e study of Development chemistry.
To review optimization data and process validation report and BMR of API Pilot
To review Technology Transfer documents like MFC,PDR,IPS,Specification and STPs
of KSM,Raw material,Intermediate,API including
Release of all specification, BOM and Master Recipe in SAP and also handing SAP
related activities like Batch Manufacturing, Batch Released COA etc.
To review Protocol and report related to Method validation, Method equivalency
and Method verification and Method transfer.
To review of documents and relevant raw data of references standard/working
standard, characterisation include elemental analysis of 1H NMR,
13C NMR, IR, Mass, XRPD, Chromatogram, LC MS.
Qualification documents of Equipment and Instruments,Log books as well
experimental data and Lab journal of MCD etc.
To review manufacturing documents like MFC,BMR,Process validation Protocol and
report,Stability protocol and report, Sampling protocol and stability data
To review and evaluate the documents,facilitates its usage for commercial purpose
To review Change controls, Deviation, Incident and Risk Assessment.
To check the system compliance of MCD and API Pilot Plant and assist in system
audit like SOPs review, log books and Journals
To compile DMF and its submission as per regulatory requirement of Particular
country. Also eCTD publication through software.
To evaluate queries raised by regulatory authority/Customer and prepare draft
To review Deviations, RAF, Incident, CCF, PVP,PVR and CAPA etc.
To maintain life cycle management of product through variationAnnual report and
To send DMF/amendments/supplements to counterparts in respective contries.
To review out source DMF for all market such as US,EU,Brazil,ROW etc.
To compile amendments,annual reorts,DMF/CEP as per regulatory guide line and
take care of DMF extension.
To evaluate change notification/and its impact for all market.
To communicate with vendor for API related issues for outsource DMF.
Planned small scale batches i.e. mg, gm, & scale-up with the help of literature.
Expertise of Journal Writing and Documentation as per the Clients’ requirements.
Knowledge on cyanation reactions using KCN,NaCN, &CuCN and also aware of
hazardous nature of these reagents, its decomposition process.
Worked on various metal reagents like n-BuLi, tert-BuLi, LDA, DIBALH, NaH, LAH,
NaBH4, NaCNBH4, etc.
Succesfully carried out various name reactions like Suzuki coupling, Vilsmeir-Heck
reaction, Buchwald reaction, Mistunobureaction,Grignard Reaction etc.
Undertook projects, which involved the reactions like esterification, nitration,
bromination, alkylation, condensation, protection-deprotection, cyclasation,
reduction, oxidation, salt formation etc.
Familiar with the drying process of different solvents like acetone, DCM, acetonitirle
, THF/Diethyl ether, DMF/DMSO, EtOH/MeOH, Benzene/Toulene.
Purification techniques used;
High vacuum distillation
Using preparative TLC
Course School / College
2008 66 %
H.S.C G.H.S.E.B 2004 85 %
S.S.C G.S.E.B 2002 88 %
DMF Review and Submission: Review In House and out source DMF and submission of
DMF via CESP,Eudralink and eCTD.Query response and Variation filing for regulated
Computer Skills: Includes Microsoft Office; Adobe Photoshop,Corel Draw; System
maintenance; Software installations; Internet browsing, Drug designing softwares like
CHEMDRAW, CHEMSKETCH,CHEMOFFICE,CESP,Eudralink and eCTD etc.
Piramal Discovery Solution,
Contact No. 9925206580
I hereby declare that the above mentioned statements are true and correct.
Hiren D. Shah
Cell no. +91 9428386906