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Prabhusankar Rajasekaran

Prabhusankar Rajasekaran

Manager-Quality Control

DFE Pharma India LLP

Chennai, Other

11 Years experience in Pharmaceutical Quality Control. Have strong exposure in Method development , validation, Instrument maintenance like HPLC, GC, UV-Vis, AAS. Strong exposure in QA, Tech transfer, Regulatory Audits, Lab set up, Ref standard maintenance, stability studies, documentation skills, ISO, Implementation of 5S, 7...

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Accept the Blaming and give the CREDIT to others; "From the moment I learnt to speak, I was told to listen".
Quality Head-Pharmaceutical
Career medium 02

DFE Pharma

Head-QC

Heading the QC team as Manager-QC and supporting the MCC, CMC Production. Currently working on Validations and set up the QC lab with new Instruments/Equipments .

Career

Shasun Biotech R&D Centre

Head-QC

Method development, Assay validation, water validation, Optimization of all the methods, Writing monograph to IP, Implemented the Regulatory system in the Dept.

Shasun

Officer

Shasun Pharmaceuticals Ltd, Cuddalore, Tamilnadu

Asst.Manager

Section Head-HPLC

Shasun Pharmaceuticals Ltd

Section Head

Leading the HPLC section with 23 HPLCs

HPLC Lab

Sr.Executive

Products : 32 products including USFDA approved products
Job Responsibilities:
Total Responsibility for overall functioning of the Quality Control Laboratory in accordance with cGLP and principles of GMP including Instruments
Leading the HPLC section, monitoring the analysis of API in process, reaction monitoring, cleaning validation samples, and final drug. To ensure that all the relevant documents are completed and maintained online
Responsible for internal audit & compliance of the quality system to meet the regulatory requirements
Preparation of SOPs, Specifications, STPs & all other such documents / protocols related to quality control analytical laboratory in coordination with QA
Train and develop all QC staff on cGLP, analytical techniques and their evaluation on periodical basis
Maintenance of analytical Instruments, calibration and Validation of Equipments/Instruments, method validation as per ICH Guideline.
Regulatory audit exposure including handling of Deviations, Change controls and OOS
Co-ordinate with other Depts. for routine activity and QC Dept.
Investigation of the customer complaints and taking measure against them

Career medium 01
Career

TTK-LIG R&D Centre

Asst.Manager

TTK-LIG Ltd

Asst.Manager

Method development for new projects and validation as per cGMP
Analysis of In process and final bulk samples of Medical devices
Documentation as per ISO standards
Handling of Instruments like HPLC, GC-MS, AAS, etc.
Stability Studies of Drug Substances and Drug Product as per established In-house, USP, Ph/Eur. and BP by HPLC.
Experienced on setting up a new analytical laboratory with sophisticated instruments and utilities.Calibration and maintenance of all Analytical Instruments.

Career medium 03
Career
Career medium 06

Shasun Biotech R&D Centre

Officer

Products : Recombinant Streptokinase, Interferon, GCSF
Job Responsibilities:
HPLC Method Development and validation as per ICH guidelines for analysis of Recombinant Proteins.
Peptide Mapping, Analysis of Samples in SEC-HPLC, PREP-HPLC.
HPLC Method development to separate the positional isomers of proteins using PREP columns in PREP HPLC.
Act as a certified internal Auditor covers ISO and cGMP.
Biochemical assays like Bradford, Lowry, SDS PAGE, Endotoxin and Western Blot.
Analysis of In-process materials and finished products, all raw materials, as per the validated established methodologies.
Raw material analysis and STP writing.
Knowledge of analysis in checking specifications, SOP's and other important audit related documents.

Career

JK Pharmachem Ltd

QA/QC

Job Responsibilities:
Analysis of In process and final bulk samples of Pencillin-G and Pencillin-V.
Maintenance of all the shift activities
Handling of Instruments like HPLC, GLC, Colorimeter, etc.
Analysis and Certification of Final Drug
Calibration and maintenance of all Analytical Instruments
Receiving and storage of Chemicals, Ensure that all work is accurate, Precise, properly documented and Performed with in GLP guideline

Career medium 03
Career

Jamal Mohammed College, Bharathidasan University

M, Sc Chemistry

Govt. Arts College, Chidambaram

B, Sc Chemistry

P.R.G.Hr.Sec.School