Quality Control Training

Profile

V.Muthuvel

Mobile: 098******** E.Mail:

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

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

Aspiring for job assignments in Quality control Microbiology with a

reputed pharmaceutical organization preferably in Pharmaceuticals & Biotech

industry.

Synopsis

> M.Sc., M.Phil (Microbiology) professional with 12.0 years of experience

in reputed pharmaceutical industry Quality control area in Microbiology

department.

> Currently associated with Kudos Chemie Ltd., as Head Microbiology Gained

technical expertise from all type of validation activities related

pharmaceutical microbiological analysis.

> Acquired comprehensive exposure in planning and organizing day-to-day

Quality control activities and executing tasks on a timely basis.

> Creating Standard Operating Procedure (SOP) & Standard Testing Procedure

providing training for the same.

> Possessing knowledge of QC aspects and cGMP as per Aseptic manufacturing

of sterile Drugs.

> A professional with a proactive attitude, capable of thinking in & out of

the box.

> An energetic, self-motivated team player with hands on experience in

requirements gathering, examination, evaluation and customization.

Career Contour

> Presently working in KUDOS CHEMIE Ltd., (ISO 9001:2008, ICH Q7A, EDQM )

as a Sr.Manager Microbiology and QC at Derabassi Unit from June 2007 to

till date.

> More than Three and Half Years of experience in SHASUN CHEMICALS AND

DRUGS Ltd., (US FDA, ISO 9002:2001,) as an Officer Q.C in Microbiology at

Cuddalore Unit from November 2003 to June 2007.

> Three Years of experience in Medispan Pharmaceuticals Ltd., (Formulation

division) as an Executive Microbiologist (ISO 9001) in Chennai From

December 2000 to November 2003.

Skill Set: - Quality Control Microbiology

Key Deliverables

> Microbial limit test method development and method validation for raw

material, finished goods as per BP, USP, EP, IP and client method.

> Sterility testing method development and method validation for raw

material, finished goods and sterile medical devices as per BP,USP,EP,IP

and client method.

> Bacterial endotoxin test (gel clot method) method development and

method validation for raw material, finished goods and sterile medical

devices as per BP, USP, EP, IP and client method.

> Preservative efficacy test method development and method validation for

various sterile and non-sterile products as per BP, USP, EP, IP and

client method.

> Antibiotic and vitamin assay method development and method validation

(cylinder plate method -1 level, 2 level and 3 level assays) as per BP,

USP, EP, IP and client method.

> Growth promotion test and self life validation for prepared Medias.

> Label claim sensitivity study for lystae and cell count for biological

indicators.

> Bacterial identification test by using API kits.

> Sterile and Non sterile Area validation.

> Water validation( by pour plate and filtration method)

> Isolator Environmental monitoring validation

> Environmental monitoring by using settle plate, air sampler, contact

plate and swab.

> Validation study for disinfectant, swab recovery, contact plate recovery,

garments recovery, UV lamp effectiveness.

> Validation and calibration for various instruments like Autoclave,

incubators, hot air oven, laminar air flow and bio safety hood.

> Preparation of IQ, OQ, PQ for various microbiology lab instruments.

> Co-ordination with QA OOS investigation, deviations handling and change

controls.

> Preparation of validation protocols and validation reports.

> Documentation & preparation of SOP.

> To train the new microbiologist as per training scheduled.

> Organizing training programs for operating personnel and documenting it.

> Monitoring the proper documentation process.

Significant Highlights

> Successfully headed the team for USFDA (United States food and drug

administration) regulatory audit at Shasun Chemicals and Drugs Ltd.,

without any major observation.

> Successfully headed the team for GSK, Procter and Gamble, Sanofi Aventis

and Sun Pharmaceutical Ltd as a customer audit at Kudos Chemie Ltd.

> Actively participated in a team which faced USFDA (United States food and

drug administration) regulatory audit.

> Faced many international client audits.

> Actively participated in internal audits and audit preparation.

> Actively participated in WHO GMP audit.

Academic Project

DISSERTATION:

Allergic Bronchitis: Determination of Occupational Hazards in and around

Sivakasi by capture IgE ELISA and Remediation by Ayurvedic Therapy.

PAPER PRESENTED:

Marine Algae: Whither an Alternative for Antibiotics

SEMINAR ATTENDED:

Attended Aqua - Terr Annual symposium organized by School of Biological

Sciences M.K.U. held at Madurai.

WORKSHOP ATTENDED:

"Mass Cultivation of Bio- Fertilizers" Conducted by Dept. of Botany, ANJAC,

Sivakasi.

Workshop on Basic Technique in Modern Biology organized by the Dept. of

Biotechnology ANJAC, Sivakasi.

On Job Training

Preservative efficacy test training given by CHENNAI INDUSTRIAL COOPERATIVE

ANALYTICAL LABORATORY (MICAL) From 27th June to 26th Sep 2001.

< Culture maintenance.

< Culture suspension preparation.

< Media preparation.

< Handling of glassware's and samples.

< Interpretation of results.

< Antibiotic Assay and Vitamins Assay.

< Sterility testing.

> Bacterial endotoxin test training:

< Endotoxin and lystate reconstitution.

< Label claim sensitivity of lysate.

< Endotoxin standard curve.

< Method validation preliminary screening and

inhibition/enhancement.

< Interpretation of the results.

> Good manufacturing practice (GMP)

> SAP Nucleus Team member in Quality management module by Spectra lab.

Scholastics

2007 M.Phil (Microbiology) - from Annamalai

University.

2000 M.Sc. (Microbiology) from Ayya Nadar Janaki Ammal College

(ANJAC),

(Madurai Kamaraj University.

1998 B.Sc. (Botany) from Vivekananda College, Madurai

(Madurai Kamaraj University).

Personal Dossier

Date of Birth : 09th September, 1976.

Present Address : C-2, House No.28, 2BR, Gulmohar city, Derabassi-140507

Punjab, India.

Permanent Address :K.S.K Pudur, Viruthalaippatty (P.O),

Vedasandur(T.K), Dindigul(D.t)

PIN:624701, Tamilnadu, India.

Linguistic Abilities : Tamil, English & Hindi.

Nationality : Indian.

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