QA/QC

N . RAJKUMAR,

E mail:

n ******@**********.***

Mobile: 973-***-****

SUMMARY

A highly qualified person with over seven year experiences in Quality Assurance and Quality

Control (QA/QC) department for Biopharmaceutical and CRO sector. Possess enough

communication, team management and problem solving skills. Looking for a challenging

position in a renowned organization.

PROFESSIONAL STRNGETHS

• Co-ordinate with Sponsor audit and other regulatory inspections.

• Conduct in-house audits, data verification and document control system.

• Hands on experience in small as well as large molecule.

• Ability to handle a team and work independently as well.

EXPERIENCES

1) Present Organization

Name of Organization : Clinigene International Ltd (A Biocon Company)

Designation : Executive in Bioanalytical Laboratory

Duration : 01/01/2011 to Till date

Area: QC Team Period: 01/08/2012 to till date

Job description

• Review of experimental data for method development, method transfer, method

validation and sample analysis both non-clinical (GLP) and clinical (GCLP) studies.

• Review of Study plan and Study Report, raw data, usage log books, annexure, etc.

• Ensuring the updating of experimental records.

• Ordering and updating of chemicals/reagents stock.

• Any other responsibilities assigned by Management and HOD.

Area: Study Personnel Period: 01/01/2011to 30/07/2012

Job description

• Method validation and sample analysis for Pharmacokinetics and Toxicokinetics

Assessment of Biopharmaceutical product using CLIA and ELISA based platforms.

• Maintenance and calibration of ADVIA Centaur.

• Preparation and Review of SOP, Equipment qualification documents, etc.

• Recording of facility related activities in relevant log books and annexure.

2) Past Organizations

Name of Organization : Biocon Ltd

Designation : Executive in Bioanalytical Laboratory

Duration : 03/05/2010 to 31/12/2010

Area: QAU

Details of Work:

• To perform facility, process and study based inspection in Bioanalytical laboratory and

other laboratories performing work in support of GLP and GCLP studies.

• Review of SOP (BAM/IOP/EOP/STP)’s related to the experiment and facility, study plan

or analytical plan, method validation protocol and reports, deviations, change control,

equipment qualification and calibration records, etc.

• Preparation of audit plan (schedule), audit finding reports and statements, etc.

• Verification of instrument generated raw data, usage logbooks and calculations etc.

• Personally monitor the study sample analysis by using ELISA, RIPA, CLIA and HPLC.

• Document control system: Issuance of SOP’s and annexure, maintenance of master

SOP’s, deviations and CAPA documents, archival system, etc.

Name of Organization : Avesthagen Limited

Designation : Officer in Biopharmaceutical division

Duration : 01/02/2008 to 16/04/2010

Area: Analytical Development & Quality Control Department

Nature of Work:

• Hands on experience in the purification of biomolecules using various chromatographic

techniques like hydrophobic interaction (RP), Size Exclusion, and Tryptic peptide

mapping – HPLC methods.

• Analysis of monoclonal antibodies and protein molecules (DPO, Enbrel, Rituximab, tPA,

BVZ, etc) from Upstream and Downstream process by using competitive and sandwich

ELISA methods.

• Carrying out stability studies (preparation of stability calendar, stability sample analysis

-F/T, 2-8 C, 25 C & - 20 , compilation of results, etc).

• Preparation of SOP’s, DRS, COA, stability calendar, etc.

• Calibration of instruments as per SOP.

Name of Organization : Medopharm Pvt. Ltd

Designation : Chemist in Quality Control Department

Duration : 29/09/2005 to 21/01/2008

Area: QC

Nature of Work:

• Analysis of in-process, finished product and stability analysis of tablets and capsules by

using HPLC, GC, FTIR, UV-Spectrophotometer, etc.

• Collection of validation samples from GMP area, analysis and compilation of results.

• Carrying out stability studies (preparation of stability calendar, Real Time and

Accelerated - sample analysis, compilation and reporting, etc).

• IPQC checks and line clearance in GMP area.

• Preparation of SOP, review and rectification of BMR and BPR.

Instrument Handled

• ADVIA Centaur (Siemens), Gen 5 secure (Biotek plate reader).

• HPLC: Waters with (Empower - 2), Agilent with (Chemstation)

• GC: Perkin Elmer (Total chrome), Agilent with (Chemstation)

• UV Spectrophotometer, Fourier Transform – IR, Karl Fischer Titrator

Educational skill

M.Sc. Biochemical Technology: Periyar University, Salem - University 1 st (April

2005).

B.Sc. Biochemistry: Bharathiyar University, Coimbatore - 72.0 % (April 2003).

Computer skill

Working Knowledge in Microsoft Windows & Internet Applications.

Personal Details

Date of Birth : 25.04.1983

Father Name : R. Nagarajan

Marital Status : Married

Languages Known : Tamil and English

No - 50, Kakkayankadu, Sanaarpalayam road, Tiruchengode,

Permanent Address :

TN - 637209

Declaration

I assure that all the above furnished details are true and correct to the best of my knowledge.

Date:

Place: (N.RAJKUMAR)

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