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[QUOTE=Guest-IJT;101678]I have total 3.4 years of pure downstream processing experirnce with good knowledge of filters and instruments used like TFF,CENTRIFUGE,CHROMATOGRAPHY(anaion,cation exchanger and hydrophobic interaction).good knowledge of cGMP and maintaing IT.

GO THROUGH MY CV FOR INFORMATION AND LOOKING FORWARD FOR INTERVEIW TO DISSCUSS MORE ON MY EXPERIENCE.

MIHIR PATEL
E-mail : mihirs_world AT yahoo.com
OBJECTIVE :
Perceiving a challenging career in professionally managed, system driven organization to contribute my best
efforts towards the interest of the organization in a position that utilizes my skills while furthering my personal
and professional goals as well as to contribute strong quality skills, expertise and experience in Biotechnology
and develop myself as a valuable asset for the organization.

PROFESSIONAL JOB SUMMARY

Reliance Life Sciences, Navi Mumbai From September 2007 till Date

Currently working in the company’s cGMP PLASMA PROTEINS Manufacturing Facility.

Work Profile in the organization as an Executive

Expertise in carrying out downstream purification process of therapeutic plasma proteins like albumin, IgG, thrombin, fibrinogen, Factor VIII.
Monitoring, Control and troubleshooting of product specific production / process operations.
Preparation of various SOPS based on GDP guidelines.
Finalization of Batch Manufacturing Records, and review of the same.
Actively participated in SAT.

Carried out validation documentation of Autoclave(ctp,IQ,PQ,OQ).

Competent enough in allocating shift responsibilities at par and leading the team by getting it done in required time.
Possess knowhow about all the ICH and other cGMP based guidelines pertaining to manufacturing of Biological drugs.

Successful contribution as a team member in Indian FDA, Domestic and International Client audits such as Egypt Audit and IMB (Irish Medicine Board).
Proper Technical coordination with the Quality and R and D personnel’s in the company.
Effective and competent troubleshooting of critical operative steps during the cGMP manufacturing of API / Bulk drug substances.
Thorough Knowledge of handling of DCS (Distributed Control system By Siemens PCS 7) and connecting instruments like CIP skid, TFF, Pasteurizer.

Apart from the above mentioned core competencies I am able to carry out the following operations effectively and potentially…..
Adherence to Standard operating procedures, product specifications and safety requirements.
Entering as well as reviewal of data in Quality Records, Batch Manufacturing Records and associated checklists.
Product handling for pharma / biogeneric drugs.
Reporting of non conformities and process deviations during product processing and implementation of corrective/preventive action in no time for the same.
Calibration of all Analytical Instruments in production.
Strict adherence to the established procedures and policies of the company pertaining to Quality, Environment, Health and Safety norms.
In Process product sampling, inspection and storage of the same.
Monitoring area cleanliness of defined and classified areas.
Training of Production Personnel’s for process and product handling.
And involved in validation of process in vessels from water trial to media hold in tanks upto validation batches. I have involved in the process development of albumin production from fraction v and ppf paste.

Technical Knowhow

Has technical expertise in packing of following types of protein purificative columns like Q Sepharose (70L)
Operation and maintenance of Tangential Flow Filtration.
Proficient in carrying out Integrity Tests of various types of filters and cassettes like MILLIPAK 100, 60.

Projects Worked Upon

Successfully completed project on “MICROBIAL TECHNIQUES” form JIVAS (Jain Institute Of Vocational Studies) , Bangalore
Successfully completed project on “IMMUNOLOGICAL TECHNIQUES” form JIVAS (Jain Institute Of Vocational Studies) , Bangalore
Successfully completed another project on “RECOMBINANT DNA TECHNOLOGY” from Garden City College, Bangalore.
Successfully completed another project on “PLANT BIOTECHNOLOGY” from Garden City College, Bangalore.

Computer Skills
Precision in working with all the Microsoft Office Tools like MS Word, MS Excel, MS Power Point, etc.

Training undergone
Six Weeks (17th Sep-26th Oct, 2007) Training in “BIOPHARMACEUTICAL PRODUCTION AND ENGINEERING”
at BIOZEEN, Bangalore.

District head of the for the safety monitoring in case of emergency.

Educational Qualifications

Masters in Biotechnology

From Garden City College (Bangalore University), Karnataka with 74% Marks in 2007

Bachelors in Biotechnology

From Garden City College (Bangalore University), Karnataka with 74.5 % Marks in 2005.[/QUOTE]

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