Vikram Perumal

SUMMARY

I am a qualified Analytical Chemist holding Masters degree in Inorganic chemistry and a Master

degree in Business Administration, with Impressive and result oriented career spanning over 14+

years in Analytical support functions both independently and or in a team with distinction of

steering improvement initiatives with focus on streamlining & managing operations with proactive

planning, introducing new concepts, steering change etc with consistent contribution to increased

performance.

EDUCATIONAL QUALIFICATION

Master of Business Administration(MBA), Specialization in Human Resources

Sikkim Manipal University

Master of Science (M.Sc.) (Chemistry),

Institute of Science, University of Bombay, Specialization in Inorganic Chemistry

TECHINICAL QUALIFICATION

Diploma in Chemical and Instrumental Analysis, From C.C. Shroff Research Institute, Mumbai.

PROFESSIONAL EXPERIENCE:

1. Working for Higher Pharmatech Pvt Ltd, Navi Mumbai

(Subsidiary of Strides Arcolab Ltd, Bangalore).

Research based organization developing Innovative and Proprietary Pharmaceutical Products.

As Head Analytical Services Department, From December 2009 till date

2. Worked for STAR (Strides Technologies and Research), Bangalore,

Research based organization developing Innovative and Proprietary Pharmaceutical Products.

(US FDA, MHRA, MCC, TGA, UNICEF, W.H.O.) As Team Leader Analytical Services Department

From December 2004 till December 2009

3. Worked for Indoco Remedies Ltd,Mumbai

in RESEARCH AND DEVELOPMENT CENTRE, Mumbai,

as an Analytical Officer, From September 1998 till Dec’2004

RESEARCH SKILLS:

• Develop Analytical Method for Drug Dosage Forms (Powders, Tablets, Capsules, Liquids, and

Suspensions).

• Validation of analytical methods: Preparation of protocols; reports, development; and validation of

the pharmacopoeial methods.

• Developed/optimized methods based on HPLC: reverse phase, normal phase, Chiral stationary

phase; detection methods using UV PDA, Fluorescence.

• Spectrometric analyses using UV, Fluorescence, and IR.

• Stability Study for Drug Dosage Forms (Powders, Tablets, Capsules and Suspensions); ANDA projects;

Brazil projects and as per ICH guideline.

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MANAGEMENT SKILLS:

• Leading team of 16+ scientists to support the development of NCE, ANDA, BRAZIL, EUROPE projects.

• Manages analytical budget, procurement and maintenance of Reference standards, columns,

chemicals and reagents.

• Accountable to responds the technical support to regulatory bodies.

• Team building, inspiration and team achievements in specified time frame by improved efficiency,

knowledge and skills of all team members.

PRESENT JOB RESPONSIBILITIES:

Main responsibility:

• Planning day to day activities, supporting the data generation for ANDA development submissions

and stability studies

• Responsible for the approval of development of the analytical methods for Client projects.

• Preparation and review of development reports as per the requirements of FDA.

• Accountable for execution of projects to deliver projects in specified timelines set by the

organization.

• Execution of budget of ASD FD.

• Conducting stability studies as per ICH guidelines and data evaluation.

• Handling of Change Control, Deviation and Incident.

• Responsible Analytical Instrument Qualification and Validation.

Other responsibility:

• Monitoring GLP and cGMP compliance.

• SOP approval for different instruments.

• Review and Approval of stability study protocols, Tech transfer protocols, validation protocols

And their effective execution and reporting.

• Manages procurement, maintenance reference standards: preparations and maintenance

of working standards.

FIELD OF EXPOSURE:

• Preparation of Physiological compatibility protocols as per SPC,PI and planning and execution the

same

• Responsible for cGLP maintenance in the lab, and imparting training to fellow executives and senior

executives and new joiners.

• Method development of different dosage (Oral, Parental) formations for ANDA and other regulatory

requirement procedure.

• Review of presentation and development reports of ANDA Submission, Stability Data

• Method Validation as per ICH guidelines.

• Monitoring Method transfer.

• Handling corporate stability department and all stability outsourcing of External Lab

• Handling of Change Control, Deviation and Incident.

• Responsible Analytical Instrument Qualification and Validation.

• Additional responsibility of group Stability for ANDA and Global submission.

• Responsible for Q integration.

• Dissolution profiling

• Planning invitro profiles against innovator products (RLD) in five media according to OGD/official

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media.

• Forced degradation studies

• Formulation Development Process studies

1. Formal Stability Studies

2. Development Stability Studies

3. Photo Stability Studies

4. Autoclaving Samples Studies

• Drug Product Compatibility studies

1. Drug excipient Study.

2. Rubber Closure Study.

3. Physiological Solution compatibility Study.

4. Filter compatibility Study.

• Responsible for analysis of innovator and exhibit sample, intended for ANDA submission.

• Analysis of development samples from formulation development department and documentation of

relevant data

• Documentation and completion of analysis reports and coordination of related work

• Documentation work as per regulatory requirements.

• Instruments calibration and maintenance

• Preparation of specification &Justification for specification

Auditory Support

Support to plant for regulatory audits like US FDA, MHRA, ANVISA, TGA audit.

Client Audit Faced

1. Pfizer

2. Teva

3. Jamjoom Pharma

4. J & J

5. Ranbaxy

ANALYTICAL INSTRUMENTS HANDLED

• HPLC with UV, PDA, and RI Detector (Waters, Shimadzu, Agilent and Jasco)

• Headspace GC (Agilent )

• FTIR (Shimadzu, Jasco.)

• Spectrophotometer (Shimadzu, Jasco)

• DSC/TGA (Waters)

• Dissolution Apparatus, USP Type I, II(Electrolab, Varian and Distek)

• Particle Size Analyzer (Malvern Master Sizer 2000)

• Particulate Matter Counter (Pamas)

• Potentiometer / KF Titrator (Labindia, Veego Matic)

• Atomic Absorption Spectrometer PG 990

• Others –DT Apparatus, Friability Tester, Polarimeter, Viscometer, etc.

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PROFESSIONAL ACHIEVEMENTS:

1. FDA Approved Analyst by Government of Maharashtra.

2. Went on deputation to Belta Pharma(Milan Italy) for Method transfer, Stability studies

3. Co ordinated with USFDA audit in Strides. ( Oral, Injectable and Betalactum division.)

4. Successfully completed Method transfer for GSK both US and UK.(Contract stability studies)

PERSONAL PROFILE

• NAME : Mr. Vikram Perumal

• GENDER & AGE : Male & 39 Years

• MARRITAL STATUS : Single

• 13th October, 1972

DATE OF BIRTH :

• NATIONALITY : Indian

• FAMILY : Parents,Sisters and Brother

• PERMANENT ADDRESS : Mr. Vikram Perumal

C/15, Ashirwad,

Poonam Nagar,

Mahakali Caves rd

Andheri (E)

Mumbai 400 093.

• A/503, 5th Floor,

COMMUNICATION ADDRESS :

Glitter Mahavir Classik

Opp L&T gate no 5.

Saki Vihar Rd, Powai

Mumbai 400 072

• CELL NO : +91-982******* & +91-922*******

EMAIL ADDRESS : abyuk7@r.postjobfree.com

REFERENCES:

1. Dr Deepak .D Joshi working as Asst. Vice President –Analytical Services & Regulatory Affairs

(Wintac Limited)

2. Mr.S .C.Kale Working as A.G.M Analytical R&D ( Microlabs – Mumbai)

3. Mr. Ajay Dere Working as A.G.M Analytical R&D ( Glenmark –Nasik, sinnar)

4. Dr.Suneet Padgaonkar working as D.G.M QA (Novartis)

Contact details will be provide as an when required

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