Food safety consultant

RESUME

J. Jerry Clement

Avenir Industries, P*-121 SAIF Zone.

Sharjah, UAE. Post Box N0-122506.

E-mail: ***************@*****.***

Mobile No.: +971*********

Nationality : Indian

Date of Birth : 28/05/1985

Marital Status : Married

Strengths :Responsible, Optimistic, Social

Languages Known :English, Tamil & Kannada

Driving License: Valid UAE License (A)

Objective

To work in a dynamic and growth oriented company wherein I will be able to put my knowledge and experience in the field to use it in best possible manner for the growth of the company and self.

Summary

Over 8 years of protein purification, Bio-pharmaceutical, Food industry, for its development and manufacturing.

Technology assessment, project planning, commissioning and qualification of manufacturing facilities, technology absorption, material preparation for preclinical and clinical study, commercial manufacturing of biologics, ISO, HACCP training and implementation, food manufacturing and for regulated market.

Academic Qualification

Qualification

University/ College

Duration

Mark Secured

MBA in Production

MKU University

(2013-2015)

61%

B.Tech in Industrial Biotechnology

A C college of technology, Anna University, Chennai

(2004-2007)

CGPA: 7.056

Diploma in Chemical Engineering,

SRV Polytechnic College, Sembodai, Tamilnadu

(2002-2004)

86.5%

Work Experience (July 2015 to Till date) Avenir Industries FZE, Sharjah (UAE).

Working as a Jr. Manager

Qualification and validation of process equipment.

Trials of production on various methods to overcome constraints in yield and quality.

ISO, HACCP, SOP document preparation.

Production planning and maintenance.

Conduct internal Audit, ISO, HACCP implementation; serve as a Food Safety Team Leader.

cGMP, GMP, ISO,HACCP training conduct to all employees.

Work Experience (Nov 2008 to Feb 2012 and April 2013 to June 2015) Biocon Ltd, Bangalore.

Manufacture of ALZUMAB, Bmab-100 (Bevacizumab), Bmab-600 (Humanized anti CD6 monoclonal antibody), BMO-2 (Adalimumab), Bmab-200 (Trastuzumab), Nimotuzumab (Biomab-EGFR).

Commissioning and qualification of new biologics plant.

Part of Layout discussions for the following.

oEquipment positioning layout

oEntry / Exit layout and rational document.

oPreparation and review of equipment qualification documents.

Execution of qualifications.

oChromatography column

oChromatography system

oColumn packing skid & slurry vessel

oBuffer Preparation vessel

oTFF

oTemperature Control Unit

oClean room Equipments

Worked with QA for document preparedness and technical assistance, CAPA, change control.

Monoclonal antibody purification Process: Clarification by centrifuge & filtration, chromatography, UF/DF, viral filtration and formulation.

Documentation: SOP/EOPs, BMRs, Batch reports, process analytical tool reviews, Change controls, Deviation handling, Validation protocols and equipment qualifications (DQ, FAT, SAT, IQ, OQ & PQ).

Scale up: TTD review, new document preparation, technical discussions and trouble shooting.

Certification

ISO 22000:2005 Lead Auditor (FSMS) Course completed.

Project Work

1.Bio Fuel (Ethanol) production by Saccharomyces cerevisiae. (UG Thesis)

2.Attempt to characterize a biologically active extracellular protease From a new Bacterial isolate. (May 2006)

Declaration

I hereby declare, that all the information furnished above is correct and true to best of my knowledge.

Place: Bangalore yours sincerely

Date: J. Jerry clement

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