Clinical Research Lab Technician

CURRICULUM VITAE

Mrs. Rupali Vishal Kale,

Mob. No- 902-***-**** Email ID: - ******.*****@*****.***

Mrs. Rupali Vishal Kale,

M.Sc.(Microbiology)

Place of residence : Plot No-28, New Ganesh Nagar, Garkheda, Aurangabad.

Objective:

Become a part of well esteemed organization that offers challenging oportunities in pharmace-utical field to enhance my potential and competencies for effective contribution in organization growth & its business.

Areas of Interest:

Quality control.

Quality Assurance.

Research executive in R&D department.

Clinical Research.

Work Experience:

Quality Assurance officer in Ajanta Pharma Ltd. from 19 Apr to till date

Quality control Sr officer in Wockhardt Ltd.from 25th May 2015 to 2nd Feb 2017.

Clinical research coordinator in United CIIGMA Hospital from

March 2013 to 25th may 2015.

CURENT JOB RESPONCIBILITIES:

To prepare packing material specifications and standard test procedure and maintain its records.

To Issue packaging material specifications and standard test procedures to manufacturing site with Product/scale-up file & also as & when required to the site.

To issue packing material specifications to CQA for uploading in system.

To issuance, retrieval, storage and destruction of shade cards and approved specimens.

Follow-up for shade cards with packaging and development.

Review of change control, Deviation.

To assist in verification of finished goods documents and dispatch approval.

To assist in initiation & closure of RM/PM vendor complaints & maintain its record.

To send scan copies of RM/PM vendor complaints to CQA for further process.

To prepare monthly MIS for QA department.

To prepare control sample MIS of every month.

Approval of artwork received from packaging & development.

To assist in RM/PM rejection

Provide the documents process validation batches for DRA submission.

To assist in Release in Packaging Material/GRN in SAP

To assist for DRA related activity to DRA & R&D team for dossier submission.

Vendor complaint generation in QMS & closer of same, reviewing the CAPA for same.

To prepare PVP & PVR for process validation batches.

PREVIOUS JOB RESPONCIBILITIES:

Perform all the microbiological testing.

Water testing & all documentation regarding the respective analysis.

Responsible for the following the GDP & GMP in laboratory practices.

Interpretations of generated data and application of the same in the Formulation Development.

Preparation of media for microbial cultivation.

Performing selective test for selective organism.

Demonstration of organism morphologically by using the microscope.

Responsible for disinfectant preparation& its usage.

Responsible for taking differential pressure, Temperature & Humidity of Lab.

Bioburden Testing of in process Samples like swab, rinse water & filtered bulk produced during production of sterile products etc.

Method validation of bioburden & Microbial limit test.

Microbial limit test of raw material, finished product & stability products.

Handling of various instruments & Equipment pH meter, Hygrometer, Laminar air flow unit, filtration unit. etc.

Familiar with cGMP manufacturing procedures, regulatory procedures etc.

Calibration of all the instrument & Equipment.

Various plating method, various types of cultures, types of medias etc.

Follow all the procedure according the SOP.

Handling of various QMS documents.

Handling of excursion in microbiology lab.

Preparing trend's of water and Environmental sciences.

Prepared of annexure for water and MLT testing.

Strong attributes:

Interested in novel and innovative ideas.

Ready to imbibe new concepts and keen to take research challenges.

Interested in team working.

Good organizational and communication skills.

Have good handle in computer.

Achievements:

Completing M.Sc. Microbiology from Maulana Azad college of Aurangabad, & rank 1st in the college in year 2012.

7th in marathawata region at 12th level in the MCVC stream of medical lab technician.

Educational Profile:

Course

Board/University

Year

Academic

M.Sc.

BAMU University

2012

62%

B.Sc.

BAMU University

2009

63%

HSC

State Board

2006

80.33%

SSC

State Board

2004

74%

Personal Details:

Name : RUPALI VISHAL KALE

Address : Plot. No. 28, New Ganesh Nagar, Garkheda Parisar,

Aurangabad

Mobile no. : 902-***-****, 976-***-****.

Marital status : Married

Language known : Marathi, English, Hindi.

E mail ID : ******.*****@*****.***

Date of birth : 07/05/1988

Nationality : Indian

State : Maharashtra

Place: Rupali Vishal Kale

Date:

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