Sanju 54 U

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CURRICULUM VITAE

Objective: To obtain a suitable and growth oriented position in Quality Control /Quality assurance
department, where my managerial, analytical and trouble shooting assets can be put forward for a successful
service.

Personal details:
Name : Sanjay S Choudhari
Date of Birth : 16.08.1971
Educational Qualification : M.Sc in Bio-chemistry
Permanent Address : L I G-50, Ashok Nagar, Hudco colony
M,M Extension , BELGAUM-590016
Belgaum Dist,Karnataka
Address for Communication : SAME AS ABOVE
Marital Status : Married
Passport Number : S2104278 valid upto Nov-2028

Mail ID : ssc.choudhari@gmail.com
ssc_belgaum12@rediffmail.com
Phone No : ,+918919565768/ 9849897915
References : Mr M.S Madhusundar
Plant Head ,Quality operations
Dr Reddy’s laboratory Ltd ,
Vizag. Cell : +919538601919

Mr R Ramraj ,
VP Operations
Zydus cadila , Baddi
Cell : +917032902234

PROFESSIONAL EXPERIENCE PROFILE

Responsibility:

 Overall In-charge of Lab activities


 Qualification of Instruments and Equipments.
 Conducting Stability studies for finished products.
 Providing analytical and documentation support (including dissolution profiling of the Innovator
products) related to the ANDA and other filings
 Analytical method transfer studies for new drug substances and products
 Approval of all specifications, standard test procedures, and general test procedures for all raw
materials, in process, finished products.
 Ensuring the preparation and implementation of all standard operating procedures for the labs
functions.
 Ensuring training of the Lab personnel and Analyst qualification
 Preparation and maintenance of documents and manuals as per the GMP &GLP requirements.
 Ensuring timely service to both internal and external customer
 Participating in resolving the out of specification results via investigating the deviation to find
out the root cause for deviation in association with QA and to propose corrective and preventive
action
Other information:
 Knowledge in the calibration procedures and basic trouble shooting of instruments.
 Knowledge in the Basic computers and operating systems.
 Active member of core team for ISO-9001-2000 and NABL approvals.
 Independently handled QA/QC departments with planning & coordination.
 Core member in Suggestion & implementation of inventory control and cost reduction proposals
in 5S & Kaizens.
 Handled projects like ERP, SAP, Documentum , Track wise software , Metric stream software for
SOP Control and Quality management system & LIMS as major source of documentation.
Current assignment:

Asst General Manager-QC in Laurus Labs Ltd, Unit-2, Atchutapuram , Visakhapatam , Andhra pradesh.

From August – 2020 to till Nov-2022

Responsibility:

 Overall In-charge of Lab activities


 Qualification of Instruments and Equipment’s, method transfer studies for new drug substances
and products
 Approval of all specifications, standard test procedures, and general test procedures for all raw
materials, in process, finished products.
 Ensuring the preparation and implementation of all standard operating procedures for the lab
functions.
 Ensuring training of the Lab personnel and Analyst qualification
 Preparation and maintenance of documents and manuals as per the GMP &GLP requirements.
 Ensuring timely service to both internal and external customer
 Participating in resolving the out of specification results via investigating the deviation to find
out the root cause for deviation in association with QA and to propose corrective and preventive
action.
 Implementation of Web based application for column management, chemical management,
standard and impurities management and COA Management for quality control laboratory as a
major source of Laboratory management system
 Coordination with internal and external customers to ensure documents are arranged in timely
manner for regulatory filings.
Previous assignment:

Senior Manager-QC in Natco Pharma Ltd, Unit-IX, Mirza , Guwahati , ASSAM.

From June – 2016 to June 2020

Responsibility:

 Overall In-charge of Lab activities


 Qualification of Instruments and Equipments.
 Conducting Stability studies for finished products.
 Providing analytical and documentation support (including dissolution profiling of the Innovator
products) related to the ANDA and other filings
 Analytical method transfer studies for new drug substances and products
 Approval of all specifications, standard test procedures, and general test procedures for all raw
materials, in process, finished products.
 Ensuring the preparation and implementation of all standard operating procedures for the labs
functions.
 Ensuring training of the Lab personnel and Analyst qualification
 Preparation and maintenance of documents and manuals as per the GMP &GLP requirements.
 Ensuring timely service to both internal and external customer
 Participating in resolving the out of specification results via investigating the deviation to find
out the root cause for deviation in association with QA and to propose corrective and preventive
action.
 Implementation of LIMS as a major source of Laboratory management system
 Implementation of E-signature in Empower 3 software .

Previous assignment:

Senior Manager-QC in Amneal Pharmaceuticals Pvt Ltd, Oncology Unit, JADCHERLA

From Nov – 2014 to June 2015


 Plant approval going for USFDA, MHRA.
 This facility has Injectable manufacturing.
Responsibility:
 Overall in-charge of all quality control aspects of raw materials, Packing materials, in-process,
finished products for the sterile products in formulation unit.
 Conducting and Maintaining stability studies for various finished products as per ICH guidelines.
 Providing analytical and documentation support (including dissolution profiling of the Innovator
products) related to the ANDA and other filings
 Managing analysis of all In-process and cleaning validation samples and to provide required
support to QA functions
 Ensuring analytical method transfer studies during technology transfer
 Approval of all specifications, standard test procedures, and general test procedures for all raw
materials, in process, finished sterile products.
 Ensuring the preparation and implementation of all standard operating procedures for the QC
functions.
 Ensuring training of the QC personnel and Analyst qualification
 Preparation and maintenance of documents and manuals as per the GMP/GLP requirements.
 Ensuring timely service to both internal and external customer
 Participating in resolving the out of specification/OOT results via investigating the deviation to
find out the root cause for deviation in association with QA and to propose corrective and
preventive action.
 To follow all the instructions & directions given by Head Quality for
timely completion of the assigned tasks.
 To coordinate with R&D,CQA & Production for the proper planning &
execution of exhibit & commercial batches for US , EU markets.
 To ensure the timely launch of new product in US/EU by having
effective coordination with concerned stake holders.
 To Review and Approval of Certificate of Analysis/Trend report
after completion of review of the raw data of Raw Materials, Packing
materials, Finished Products for Regulatory submission.
 Preparation and Review of Protocol and Report for Cleaning
Validation, Analytical Method Validation and review of supporting
documents.
 Evaluation of Deviation, Incident report and Change control.
 To ensure & review calibration & AMC of all QC instruments as per
their schedules.
 To ensure all time readiness for audits.
 To ensure internal & external QC audit compliance.
 To ensure the day to day work planning does not get effected when
the deputies are on leave.
 To motivate QC staff and monitor closely the analysis time cycles to
enhance the instrument productivity while minimizing the % break downs.
 To identify the area for improving quality of work and suggest accordingly.
 To evaluate, discuss and submit performance appraisal of subordinate
staff to Head Quality on requirement.

Previous assignment:

Senior Manager- QC in Mylan Laboratories Ltd , FDF4, – JADCHERLA

From Sept – 2013 to Nov 2014


 Plant approved by WHO, MHRA.Going for PMDA
This facility has Solid Oral Dosage forms manufacturing.
Responsibility:
 Overall in-charge of all quality control aspects of raw materials, Packing materials, in-process,
finished products for the tablet, capsule forms in formulation unit.
 Conducting and Maintaining stability studies for various finished products as per ICH guidelines.
 Providing analytical and documentation support (including dissolution profiling of the Innovator
products) related to the ANDA and other filings
 Managing analysis of all In-process and cleaning validation samples and to provide required
support to QA functions
 Ensuring analytical method transfer studies during technology transfer
 Approval of all specifications, standard test procedures, and general test procedures for all raw
materials, in process, finished products for the tablet, capsule dosage forms.
 Ensuring the preparation and implementation of all standard operating procedures for the QC
functions.
 Ensuring training of the QC personnel and Analyst qualification
 Preparation and maintenance of documents and manuals as per the GMP/GLP requirements.
 Ensuring timely service to both internal and external customer
 Implementation of Data Management systems like laboratory information and management
systems, Documentum, Quality management system By Track wise and inventory control like
SAP software
 Participating in resolving the out of specification/OOT results via investigating the deviation to
find out the root cause for deviation in association with QA and to propose corrective and
preventive action.
 To coordinate with R&D,CQA & Production for the proper planning &
execution of exhibit & commercial batches for Japan , EU markets.
 To ensure the timely launch of new product in Japan/EU by having
effective coordination with concerned stake holders.
 To Review and Approval of Certificate of Analysis/Trend report
after completion of review of the raw data of Raw Materials, Packing
materials, Finished Products for Regulatory submission.
 Responsible for review of work sheet in the LIMS system.
 Evaluation of Deviation, Incident report and Change control.
 To ensure & review calibration & AMC of all QC instruments as per
their schedules.
 To ensure all time readiness for audits.
 To ensure internal & external QC audit compliance.
 Review of the SOPs, Specs, STPs & worksheets of RM, PM, SFG, FP and
in coordination with QA to fulfill the RA requirements.
 To evaluate, discuss and submit performance appraisal of subordinate
staff to Head Quality on requirement.
Previous assignment:

QC Manager in AUROBINDO PHARMA LTD UNIT-VII – JADCHERLA

From May – 2009 to July 2013


 Plant approved by USFDA, WHO, MHRA, MCC and Health Canada .
This facility has Solid Oral Dosage forms manufacturing.
Responsibility:
 Overall in-charge of all quality control aspects of raw materials, Packing materials, in-process,
finished products for the tablet, capsule, dry syrup and liquid oral dosage forms in formulation
unit.
 Conducting and Maintaining stability studies for various finished products as per ICH guidelines.
 Ensuring analytical method transfer studies during technology transfer
 Approval of all specifications, standard test procedures, and general test procedures for all raw
materials, in process, finished products for the tablet, capsule, dry syrup and liquid oral dosage
forms.
 Ensuring the preparation and implementation of all standard operating procedures for the QC
functions.
 Ensuring training of the QC personnel and Analyst qualification
 Preparation and maintenance of documents and manuals as per the GMP/GLP requirements.
 Ensuring timely service to both internal and external customer
 Implementation of Data Management systems like laboratory information and management
systems and inventory control like ERP software
 Participating in resolving the out of specification results via investigating the deviation to find
out the root cause for deviation in association with QA and to propose corrective and preventive
action
 To ensure the timely launch of new product in US/EU by having
effective coordination with concerned stake holders.
 Responsible for review of work sheet in the LIMS system.
 Coordinate with other section/department on day to day basis for
timely data collection, timely review and release of RM and PM
 To ensure timely release of the batches for distribution in market.
 Evaluation of Deviation, Incident report and Change control.
 Responsible to investigate OOS/OOT reported in QC department.
 To ensure & review calibration & AMC of all QC instruments as per
their schedules.
 To ensure all time readiness for audits.
 To ensure internal & external QC audit compliance.
 To identify the area for improving quality of work and suggest , implement accordingly.
 To conduct training classes for QC personnel.
 To evaluate, discuss and submit performance appraisal of subordinate
staff to Head QC on requirement.
Previous assignment:

 Worked as Assistant manager in Aurobindo Pharma Ltd , Unit-III, Since july-2004 to jun-2008
and rejoined Aurobindo Pharma Ltd Unit-VII , Jadcherla from may-2009 to July 2013.
Responsibilities
 To plan and execute day to day work for analysts and monitor the analysis as per GLP
requirements comprising of three sections like Raw materials, Packing materials and Working
standard qualification and maintenance.
 Coordinate with other section/department on day to day basis for
timely data collection, timely review and release of RM and PM.
 To ensure the timely submission of documents for US ,EU & ROW markets.
 Evaluation of Deviation, Incident report and Change control.
 Responsible to investigate OOS/OOT reported in QC department.
 To ensure & review calibration of all QC instruments as per their schedules.
 To ensure all time readiness for audits.
 Review of the SOPs, Specs, STPs & worksheets of RM, PM and
coordination with QA to fulfill the RA requirements.
 To ensure the day to day work planning does not get effected when
the deputies are on leave.

Previous assignment:

 Worked with Sanmar Specialty Chemicals in the capacity of Sr. Chemist Since Nov 2002 to Jun
2004 in QC Lab for 1.7 years.
 The major responsibilities were to plan and execute the work for down the level in shift .
 To ensure the required raw materials are released for production based on production plan and
to coordinate with them for in process samples checks
 Timely release and dispatches of finished goods.
 Analytical method validation of new molecules by preparing protocol and acceptance criteria’s
in coordination with R&D.
 To conduct training for QC personnel’s as per requirements.

Previous assignments:

 Started career with Shriram Institute For Industrial Research as Analyst Since Aug 1996 to Oct
2002 for 6.3 years.
 The major activities during this tenure were analysis of raw materials , finished products ,
organic and inorganic sample as per BIS standards.
 Analysis of food and water samples for microbiological parameters,
 Analysis of oils , pesticides etc
 Preparing for customer and major accreditation audits.

TRAINING ATTENDED;
 Under gone several training programs on GLP and cGMP requirements
 Under gone training in HPLC by Waters
 Time management and personnel development
 21 CFR part 11 compliance – Agilent.
 Attended ISO-9001 training and qualified certified for lead auditor.
 Completed Diploma in Pharma Regulatory Affairs from BII ,Noida.

Place:
Date: (Sanjay S Choudhari)

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