Manager Quality Assurance

RESUME

JOBBY THOMAS

********@**********.*** Contact No: 91-982*******

Objective:

Seeking a challenging and responsible career in the field of Pharmaceutical organization

where I can share and enrich my Knowledge and skills for the growth of organization as well

as individual.

WORK EXPERIENCE

:

Working as a Asst. Manager (Corporate Quality Assurance, Lab maintenance &

•

Safety) in Lafarge development Laboratory, Andheri from June 2013 to till date.

Worked as an Asst. QA Manager in SGS Laboratory, Navi Mumbai, from June

•

2012 to June 2013.

Worked as a Sr. Analytical Scientist in Analytical Research Department in

•

Novartis Healthcare Pvt. Ltd, Thane, from Nov. 2005 to June 2012.

Worked as a Research Scientist in Macleod’s Pharmaceuticals Ltd,

•

Andheri, from Jan 2004 to Oct. 2005.

Worked as a Quality control officer in Cipla limited, Patalganga

•

from Oct 2001 to Dec.2003.

EDUCATIONAL QUALIFICATIONS:

1. M.Sc. in Chemistry (Organic Chemistry) from Mumbai University (K.J Somaiya college

of science & commerce)

2. B.Sc. in Chemistry from Mumbai university (K.J Somaiya college of science &

commerce)

WORK DETAILS:

Handling deviations and OOS/OOT results, Change control and CAPA

1.

RESUME

JOBBY THOMAS

********@**********.*** Contact No: 91-982*******

Management.

2. To ensure compliance for quality systems by conducting internal audits and spot

checks.

3. To prepare Site master file, Quality manual and related SOPs.

To handle the internal and external customer audits.

4.

To train subordinates for GMP and related topics. Training and analyst Qualification to the

5.

new analysts.

Responsible for Method Development of Assay.

6.

Responsible for Analytical Method validation of Assay, Related

7.

Substances (Impurities) as per ICH guidelines.

Responsible for preparing Testing procedures and Method Development report.

8.

Responsible for preparing Validation Protocols and Validation reports of Drug Products

9.

Maintenance of reference standards & working standards and its records

10.

Responsible for Analysis of Stability sample as per protocol

11.

Calibrations of Analytical Instruments like HPLC, IR, UV, Dissolution, and KF Autotitrator.

12.

Responsible for performing & reviewing of IQ / OQ / PQ documents of various analytical

13.

laboratory instruments.

INSTRUMENTS KNOWN TO HANDLE:

Waters alliance HPLC system with Empower 2 Software.

1.

2. Agilent HPLC System with both Empower2.

3. Lab India dissolution apparatus.

4. Electro Lab dissolution apparatus.

5. Shimadzu UV/VISIBLE Spectrophotometer.

6. Perkin Elmer FTIR Spectrophotometer.

7. Metrohm KF Autotitrator for water content analysis.

RESUME

JOBBY THOMAS

********@**********.*** Contact No: 91-982*******

8. Metrohm KF potentiometer.

EXPOSED TO THE TECHNIQUES:

1. Expertise in Analytical Method Validation for quantification of Assay of

drug products and their related substances in Formulation Drug Products.

2. Analysis of Different Dosage forms like Tablets, Creams, Oral

suspensions, nasal solutions and API analysis.

3. Good team player.

TRAININGS & SEMINARS:

Attended workshop on validation school by Waters.

Attend training on GC MS conducted by Agilent technologies in Singapore.

AUDIT FACED:

Faced USFDA audit in Novartis Healthcare Pvt. limited.

PERSONAL DETAILS:

Name : Jobby Thomas

Date of Birth : 22 11 1978

Sex : Male

Marital status : Married

Nationality : Indian

Languages Known : Hindi, English, Malayalam and Marathi.

Permanent Address :

RESUME

JOBBY THOMAS

********@**********.*** Contact No: 91-982*******

Jobby Thomas

Balaji garden, Flat.no. 502, Buldg. No. 4,

Ayre village, Near Kopar railway station

Dombivli East 421201, Thane district

Maharashtra state

Present Address :

Jobby Thomas

Smit apartment, Flat.No.102, “A” wing

P&T colony, Near Aashirwad bungalow

Dombivli –East 421204,Thane district

Maharashtra state

IT Skills: Good working Knowledge in Microsoft Office, Regular use of

Internet.

Strengths : Good listening attitude, Good communication skills, hard

work and sincerity

References:

Dr. Shripad Naik

Manager

Janssen Cilag Ltd.

Mulund.

Mobile. No. +919*********

Dr. Ramesh Agarwal

Manager ( Principal Scientist )

Novartis Healthcare Pvt. Ltd.

Thane,

Mobile. No. +919*********

Declaration:

RESUME

JOBBY THOMAS

********@**********.*** Contact No: 91-982*******

I hereby declare that the above information is true to the best of my knowledge.

Jobby Thomas

Contact this candidate