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Quality Control Process

Location:
Ahmedabad, GJ, 382220, India
Salary:
$60000
Posted:
June 08, 2012

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Resume:

RESUME

K. BALAMURUGAN

OBJECTIVE

To take up a challenging career with a self-motivated positive approach that utilizes my capabilities and offers professional growth to your organization.

EDUCATION

Institute Degree Year Percentage/CGPA

Ayya Nadar Janaki Ammal College,

Sivakasi.

(Madurai Kamaraj University) B.Sc

(Chemistry) 2000-2003 71.76%

M.N.U. Thiru B. SivandhiAthithan Hr. Sec School,

Mangudi- 626111.

HSC 2000 72.5%

M.N.U. Thiru B. SivandhiAthithan Hr Sec School,

Mangudi- 626111.

SSLC 1998 82.4 %

COMPUTER PROFICIENCY

• Diploma in MS-Office

INSTRUMENT HANDLED

Steam Heat Sterilizer

Dry Heat Sterilizer

Agitated nutch filter cum dryer (Rosenmund, Jung Hung)

Vacuum tray dryers

Power Process systems like sieving blender, Ribbon blender.

Glass lined reactor

Sparkler filter

Co – Mill, Auto Filling Machine

Integrity tester Sartocheck 4+

Chemical Handling

Disinfectants

• Incidin Plus, Lyzol, Savlon, Pursue, Granediar, Savlon, Eckolin, Microgen, Alderson 2000.

Gas,

• Nitrogen, Ammonia, Carbon dioxide.

Solvents

• Acetone, Ethylacetate, Methanol, Isopropylalcohol, Ethanol.

Nature of Jobs

Crystallization process control as per Batch process record and recording observation in BPR.

Equipment cleaning and cleanliness checking before batch charging.

In aseptic area operations like Crystallisation, Filtrations, Drying, Packing.

To ensure the integrity of inputs and outputs in terms of identification quantity, quality and safety.

Storage of outputs in quarantine area with quarantine label.

Information to Quality control department through sampling advice slip for sampling and testing of outputs.

Validation

Steam Heat Sterilizer validation (By KAYE VALIDATOR 2000 & G - TeK)

Heat Distribution study and cold point detection.

Heat penetration with loads

Vacuum leak rate test.

Dry Heat Sterilizer validation

Heat penetration study (BYKAYE VALIDATOR 2000 & G - Tek)

Class 100, 10000, 100000 areas

Non-viable airborne particulate checking

Cleaning validation of reactors.

Rinse sample for analytical.

Swab sample for microbial testing.

Ensuring housekeeping and sanitation in production area.

Preparation of disinfectant schedule for class 100, 1000 areas, following and recording.

Process Simulation Study (like Media Fill Validation)

Maintaining the following records.

Filter replacement, integrity testing & sterilization record.

Garment washing & sterilization record.

Equipment usage, cleaning, maintenance & sterilization record.

Drain points cleaning & sanitation record.

Relative humidity, temperature recording for all areas.

PH meter calibration and weighing balance checking records.

Filter integrity checking by means of

Bubble point

Manual diffusion testing for Membrane filter

Sterilization of water of injection loop line, aluminium container, rubber plugs, bottles, powder processing system, SS trays.

Final powder processing, packing and sampling in aseptic areas.

Maintaining cGMP, following standard operating procedures (SOP).

Aseptic area sterilization by fumigating with formalin & Minncare.

Mother liquor extraction by resin column.

Trouble shooting & achieving targets.

PERSONAL DETAILS

Name : Balamurugan . K

Father’s Name : Kadarkarai. M

Date of Birth : 20 – 04 - 1983

Sex : Male

Nationality : Indian

Permanent Address : No. 3/31, Annaththurai Veeran Street,

Mangudi- 626111, Thirunelveli (Dist),

Tamilnadu. India

Languages known : Tamil & English

Marital Status : Married

WORK EXPERIENCE:

1) 6 years and 4 months experience in bulk drug STERILE productions, as Production Officer in ORCHID CHEMICALS & PHARMACEUTICALS LTD., It exports its API about 60 Countries. (From 19.11.2003 to 29.03.2010).

2) 6 months experience in Nectar Life Sciences as a Senior Chemist from 01.02.2011 to 08.08.2011.

3) Now working as a Senior Officer in UNIMARK REMEDIES LIMITED, from 19.08.2011 to till date.

DECLARATION

I hereby declare that the above information stated here are true to the best of my knowledge.

Yours truly,

( BALAMURUGAN. K)



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