Manufacturing Pvt Ltd

RESUME

MANIKANDAN.G Mail:

****.*.*****@*****.***

Phone: +919*********

OBJECTIVE :

To be a part of an organization which uses my expertise in its process

of growth and change, while giving ample opportunity to learn and enrich my

competencies.

Presently working as Junior Executive in Hospira Healthcare India

Pvt Ltd, Chennai, Tamilnadu in Manufacturing of Sterile Injectables

(Aseptic processing). Hospira India has got approvals from UK MHRA, USFDA,

ANVISA-Brazil, HEALTH CANADA, WHO and MCC South Africa etc.

QUALIFICATION INSTITUTION YEAR &MONTH OF PERCENTAGE

PASSING

B.Pharm Madras Medical College, Aug 2009

Chennai - 03

75.45%

(DISTICTON)

Class XII A.K.T.Academy Mat.Hr.Sec March 2005 93.1%

school. MATHS-200/200

Kallakurichi. BIOLOGY-199/200

Tamilnadu.

PHYSICS-194/200

CHEMISTRY193/20

0

Class X Gandhi Memorial April 2003 95.6%

Hr.Sec.School. (MATHS-100/100)

Thiruvennainallur.

Tamilnadu. (SCIENCE-100/10

0)

ACADEMIC PROFILE:

JOB PROFILE AND KEY RESPONSIBILITIES:

. Executing and Reviewing of Batch Manufacturing Record and Batch

Packing Record.

. Ensuring all Production activities are carried out in compliance

with Standard Operating Procedures and cGMP requirements

. Carrying out the Process as per Standard Protocols and Validated

process.

. Performing Periodic Performance Verification of LAMINAR AIR FLOW

UNIT, STEAM STERILIZATION AUTOCLAVE, VIAL STERILIZATION TUNNEL

and VIAL WASHING MACHINE.

. Executing and Reviewing of Media fill Batch Record and Media

fill Protocol

. Performing Gowning Qualification.

. Performing Periodic Qualification of Manufacturing Area.

. Performing Visual Inspection Qualification / Requalification.

. Executing Cleaning Validation and Cleaning Verification.

. Ensuring all Equipments, Instruments and Area are Validated and

Calibrated as per Schedule.

. Taking Machine Trial and Exhibit Batches.

. Executing IQ, OQ and PQ Protocols

. Raising Change Control.

. Reporting Incidents to HOD through Incident Report and involving

in Investigation and submission of Incident Report.

. Preparation of SOP, SCI and SOI.

. Imparting Training to the Subordinates.

. Ensuring Proper Documentation of Activities performed.

.

OPERATIONAL SKILLS:

. Operation of KAYE VALIDATOR and its Software, used for Validation of

Steam Sterilization Autoclave, Sterilization Tunnel and Lyophilizer.

. Operation of Steam sterilization autoclave, Vial washing machine, Vial

sterilization tunnel, Vial filling machine, Vial Capping machine and

External vial washing machine

. Operation of Zebra Printer and its software used for generation of

Outer and Inner shipper labels.

. Computer skills: MS Word, Excel, Power Point, HTML, C and C++ (DCA).

. Typing skill: 30 words/min.

CARREIR ACHIVEMENTS:

. No Deviations were observed.

. Executed more than six Aseptic Media fill Validation with Zero

Contamination.

. Learned Technical ideas and procedures pertaining to Sterilization

Validation,, Validation of Steam Sterilization Cycles, Aseptic Media

fill Validation, Tunnel Sterilizer Validation, Validation of Vapor

Phase Hydrogen Peroxide Sterilization, Validation of Sterilization

Filters, Environmental qualification, Equipment and Facility

Qualification, Qualification of Water and Air Handling Systems and

Validation and Verification of Cleaning Process using the

Manufacturing Environment as a platform.

EXPERIENCE: From NOV 2009 to till date.

AUDITS FACED:

. US FDA and UK MHRA in March and April of 2011

PROJECT WORK:

. Phytochemical Analysis and Cytotoxic studies on Leaves of Abrus

Precatorius Linn.

PAPER PUBLISHED

. The paper entitled "PRELIMINARY PHYTOCHEMICAL AND CYTOTOXIC PROPERTY

ON LEAVES OF ABRUS PRECATORIUS LINN" is published in "JOURNAL

OF HERBAL MEDICINE AND TOXICOLOGY". JHMT/03/I/2009/ 4-1/2009. ESSN:

0973-4643.

PERSONAL QUALITIES:

> Highly self-motivated & confident.

> Hard working and Highly Committed

> Quick interpretation skill.

> Time Management and Innovative thinking.

PERSONAL PROFILE

Father's name : Mr. R.Ganesan

Date of Birth : 19.09.1987

Nationality : Indian

Gender : Male

Marital Status : Single

Address : No. 1/139, Hanuman Koil Street,

T.Mazhavarayanallur,

Sirumadurai-Post,

Thirukovillur-TK,

Villupuram-Dist,

DECLARATION

I hereby declare that all the above information is true to the

best of my knowledge.

Place:

Date :

Yours faithfully

(G.MANIKANDAN)

.

.

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