CURRICULUM VITAE

Brief Information:Name : SANDIP LOTANRAO PAWARPresent Designation : AGM QCPresent Organization: Troikaa Pharmaceuticals Ltd.Current Location : AhmedabadTotal Experience : 11.5 YearsCurrent CTC : 12.5 Lacs / AnnumNotice Period : 1 MonthContact No.: : +91 8469062082Email ID : slpawar2004@rediffmail.com / slp3582@gmail.com

Summary of Experience: Pharmaceutical professional with overall 11.5 years of experience in Quality control

department and presently working as Head of the Q.C. department (AGM) with Troikaa Pharmaceuticals Ltd., Ahmedabad. This is new facility set to enter in regulatory market.

Quality Management System. Successfully faced regulatory audits like, US FDA, MHRA, TGA, ANVISA, WHO-Geneva

and many more. Well versed with regulatory market requirements w.r.t. quality documentation and

laid down quality guidelines. Experience in auditing loan license and third party manufacturers (Vendor audits). Experience in setting up a new Q.C. Laboratory. Project management. Continuously working towards meeting current Laboratory standards with that of

global regulatory requirements.

Brief Professional Experience:

Organization Location

Type of Formulation

s Manufacture

d

Period of Working Total

Period

Designation Held Major Job ResponsibilityFro

m To At Joining

At Leaving

Troikaa Pharmaceti--cals Ltd.

Ahmedabad External Preparations (Cream, Gels, Ointment, Liquids etc.)

Dec.201

5

Continue

- AGM-QC -- Setting up a new Laboratory.Overall functioning of QC Laboratory.

Jenburkt Pharmaceti--cals Ltd.

Bhavnagar OSD, Liquid Preparations, External Preparations

Sept.201

2

Dec.2015

3.3 Years

Manager-QC

Manager-QC

Overall functioning of QC Laboratory and audit management.

Page 1 of 6

Brief Professional Experience (Contd…):

Organization Location

Type of Formulation

s Manufacture

d

Period of Working Total

Period

Designation Held Major Job Responsibilit

yFrom To At

JoiningAt

Leaving

Cipla Ltd.

Mumbai OSD, Liquid Preparations, External Preparations, Injectables etc.

Jan.201

1

Aug.2012

1.8 Years

Group Leader

Group Leader

Managing Stability section and vendor audits.

Goa- Unit IX Injectables (Liquid, Pre-filled syringes, Lyophilized) and Liquid orals.

Nov.200

4

Dec.2010

6.1 Years

Analyst Section Head

Managing Finished product section of Regulatory markets

Present Job Profile:Designation : Asst. General Manager-Quality ControlCompanyDirect Reporting Team Size Proposed

: Troikaa Pharmaceuticals Ltd., Ahmedabad, State-Gujarat, India: 06 Nos. of Managers: 30 Nos.

Job Responsibilities :1) Setting up a new Q.C. Laboratory as per current international standards.2) Overall functioning of QC Laboratory.3) Ensuring readiness of laboratory for regulatory site approval audits.4)Qualification of Laboratory, Facility qualification, area qualification, Water system

qualification, Nitrogen plant qualification, Compressed air plant qualification.5) Instrument qualifications, Designing SOPs, protocols approval for qualification

activities etc.6) To ensure Technology transfer of analytical methods.7) Instrument finalization for new laboratory set up.8) To ensure GLP compliance in the Laboratory.9) To ensure training of new joining.10) Recruitment of Q.C. personnel’s.

Previous Job profile: 1Designation : Manager-Quality ControlCompany : Jenburkt Pharmaceuticals Ltd., Bhavnagar, State-Gujarat,

IndiaDirect Reporting : 23 Nos. of personsTeam Size : 23 Nos.

Page 2 of 6

Job Responsibilities: 1) Overall functioning of quality control Laboratory.2) To ensure GLP compliance in the Laboratory.3) Ensuring trouble free Regulatory inspection. Aiming zero observations. Timely audit compliances.4) To ensure timely support to regulatory affairs / customers for submission of dossiers for registration.5) Responsible for controlling laboratory activities through LIMS.6) Review and approval of stability protocols, stability schedules, stability test form,

stability test report, stability trend and stability summary.7) OOS / OOT monitoring and route cause analysis. 8) To ensure reduction in OOS / OOT / Laboratory incidences due to laboratory errors by

continue training, practicing’s GLP procedures etc. 9) Approval of final testing reports of Raw materials, Packaging materials and finished

dosage forms and timely release.10)Approval of Deviations, change controls, Analytical method validation protocols /

reports.11) Deficiency review and compliance. (E.g. For deficiencies received from various regulatory bodies)12) Review and approval of Packaging material, excipient, API, finished dosage form and stability study specifications / testing procedures.13) Ensuring timely completion of scheduled activities of Calibrations of various Laboratory Instruments / equipments.14) Review and approval of SOP’s (Instruments, Equipments, General, cleaning, operation, calibration etc.)15) Review of product dossiers prior submission to regulatory authorities.16) Vendor audits and discussion of audit observation with company management. 17) Internal audits of cross functional areas. 18) Monthly presentation of Laboratory activities to company management (QMS meeting).19) Ensuring on job Trainings and subsequent analyst qualification of new joining.20) Ensuring healthy and professional work atmosphere in laboratory.21) Leading functions of quality Assurance in absence of Head-Quality Assurance.22) Participated in Mock audits.23) Review of batch records.23) To ensure reduction in employee attrition rate by mentoring them.

Previous Job profile: 2Designation : Group leader- Stability Section Company : Cipla Ltd., Vikhroli (West), Mumbai, IndiaDirect Reporting : 17 Nos. of persons.Job Responsibilities: 1) Daily work planning and allocation of work as per scheduled pull out date of stability

samples. 2) As an audit team member, actively participated in regulatory inspections.3) To train laboratory analyst in chemical and instrumental analysis.4) Preparation and review of stability protocols (e.g.-Pre-approval / post approval for

US) as per different registration requirement.Page 3 of 6

Job Responsibilities (Contd…):

5) Discussion with R&D for stability conditions for different type of formulations.6) Review of stability schedules, stability test form, stability test report, stability

summary.7) Review of temperature excursion study protocol, thermal cycling protocols, In-use

study protocols, Add-mixture study protocols etc. and execution of study.8) Personal validation of analyst in preparatory and instrumental techniques.9) OOS / OOT monitoring and route cause analysis.10) Input in cost saving approaches.11)Preparation of stability guideline for loan license stability.12)To ensure good documentation practices.13)Stability flash report preparation and discussion with technical services and R&D

team.14)To ensure GLP compliances in the laboratory. 15)To guide subordinates during trouble shooting in routine activities.16)Auditing loan license and third party manufacturer for assessing compliance of the

site w.r.t cGMP requirements, local regulatory norms, international standards and Quality Management System. Discussion of audit observation with LL Management / technical services.

17) Preparation of audit report and review of compliance report received from LL and re- audit for reviewing compliances of critical / major observations, if required.

Previous Job profile: 2Designation : Section Head of ANDA / Registration- Finished Product

Section for Regulatory market products (USA, Europe, Australia, Brazil etc.)

Company : Cipla Ltd., Unit-IX, Verna Industrial estate, Goa. IndiaDirect Reporting : 14 Nos. of personsJob Responsibilities:I) As a Section Head:1) Daily work planning and allocation of work as per production priorities and product

type.2) To train laboratory analyst in chemical and instrumental analysis. 3) Review of In process, bulk finished product, pack finished product report and COAs.4) OOS / OOT monitoring and root cause analysis. Ensuring reduction in laboratory

errors.5) Ensuring timely releases of bulk finished products / packed finished products.6) Preparation and review of specifications / SOPs.7) Document control during audits. (USFDA, MHRA, APVMA-Australia, ANVISA, WHO-

Geneva etc.)8) As an audit team member, actively participated in regulatory inspections.9) Ensuring timely deficiency compliance. (For deficiencies received from different

regulatories like USFDA, MHRA, ANVISA, WHO-Geneva etc.)10) Preparation and review of ANDA-finished product / stability study specifications.11) Monitoring of calibration schedule of Laboratory instruments. 12) Review of method validation protocols and reports.

13) Ensuring Timely technology transfer for new products at receiving site.

Page 4 of 6

Job Responsibilities: I) As a Section Head (Contd…):

14) Involve in project meetings with R&D, ADL, QA related to Regulatory market.(Specially USFDA, MHRA, TGA, EMA, ANVISA, WHO-Geneva etc.)15) Timely submission of QC documents for dossier preparations for regulated markets.16) Review of documents (Dossier) before submission to regulatory markets.17) Conducting training for new joining.18) Trend limits setting for In-process samples and finished product stage.19) Review of training file and COA.20) To ensure good documentation practices are followed.21) To ensure GLP compliance in the Laboratory.22) To guide subordinates during trouble shooting in routine activities.23) Control sample / reserve sample monitoring.24) Preparation and monitoring of visual inspection schedule for regulatory products.25) Conducting Internal audits of formulation units.26) Personal validation of analyst.27) Develop / mentor subordinates through class room trainings. 28) Input in cost saving approaches.29) Product costing for analytical part.

Job Responsibilities: II) As a Analyst :1) Sampling and Analysis of In-process samples, Bulk finished products, Finished products, Stability samples. 2) Calibration of Instruments like, HPLC, UV-Visible Spectrophotometer, IR spectrophotometer, Dissolution Tester, Karl Fischer Instrument etc.3) Preparation of specification of regulated markets products like, US, EU, TGA, WHO- Geneva etc.4) Preparation of SOP's.5) Preparation and timely review of work sheets in TQC software.6) Timely completion of analysis in allocated time.

Educational Details:

Examination/Degree

University/board

Subjects Years Percentage

M.Sc.(Master of Science)

Pune University,Pune.

Biochemistry 2002-2004 51.35

B.Sc.(Bachelor of Science)

Pune University,Pune.

Chemistry 1999-2002 67.78

H.S.C.(Higher Secondary Certificate)

Nasik Board, Nasik.

Chemistry, Biology, Physics, English, Marathi, Geography

1997-1999 52.50

S.S.C(Secondary School Certificate)

Nasik Board, Nasik.

English, Hindi, Science, Mathematics, Marathi, Social sciences

1996-1997 64.66

Page 5 of 6

Conferences and Workshop attended: 1) Training for Quality Introduction to Good Laboratory Practice by Dr. Van zyl,

former WHO GMP Inspector conducted at Cipla, Goa. India2) Training for Quality Introduction, Good chromatographic practices to Good

Laboratory Practice by Dr.Amritpal siddhu, Former TGA auditor conducted at Cipla, Goa. India

3) Seminar attended on Impurity profile and stability testing of new drug substances and drug products by Dr.Sarangit Singh, Senior scientist / HOD, Institute of pharmacology, Panjab University. India

4) Training attended on First aid as a senior first aid trainer of Saint john ambulance association, Goa. India

5) Personal Excellency seminar conducted at Cipla Ltd., Vikhroli, Mumbai. India6) Attended IDMA seminar on Current Regulatory trends conducted at Hotel Hyatt-

Mumbai, Year- Sept. 2012.

Personal Details:Name : SANDIP LOTANRAO PAWARDate of Birth: : 03rd May 1982Address for Correspondence: : Safal Parisar-II, Flat No.: K-103, 1st floor, South

Bopal, Ahmedabad, Gujarat-380058.: Permanent address: At/Po-Pimpalgaon,Tal-Malegaon,Dist- Nasik,Maharashtrsa-423202

Marital Status: : Married Current CTC:

12.5 Lacs / AnnumExpected CTC:

Negotiable.Declaration:Above information in true to the best of my knowledge.Your Faithfully,

Sandip PawarPage 6 of 6