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Quality Assurance Pvt Ltd

Location:
India
Salary:
negotiable
Posted:
August 25, 2014

Contact this candidate

Resume:

CURRICULAM VITAE

Pranjali V. Malode

Mobile No.91-909*******

Email: **************@*****.***

Address: Trimurti 104, Asha construction, Dhatrak phata,

Nashik- 422003

Career Objective

To be a part of distinguished organization, where I can utilize my skills

and knowledge in the best possible manner and which can provide me ample

opportunities for both individual contribution and teamwork for the benefit

of organization.

Academic Profile

Degree Year Of Institute / University Percentage

Passing

M PHARM in Quality Sep-2012 67.77%

Assurance A.I.S.S.M.S College of

Pharmacy, Pune/PUNE

July-2010 63.13%

B PHARM S.M.B.T College of

Pharmacy, Nashik /PUNE

Apr-2007 76.50%

D PHARM I.P.S, Nashik /M.S.B.T.E

MUMBAI

HSC Feb-2005 55%

PUNE

S.S.C. (X) March-2003 PUNE

77.60%

Work Experience

M/s Soham Organic Pvt Ltd Nasik, Maharashtra

Designation: QA executive

Presently working as QA executive for above company an ISO 9001-2009

certified company; this is in the field of API Bulk drugs, Intermediates

(Vitamin E Acetate, Vitamin E Acetate Pharma powder, Vitamin B6)

Audit faced: Vendor audits-4

FDA inspection-1

Duration: From August 2012 to till date

Job Profile

. To ensure periodic validation and re-validation related to process and

Equipments/Instruments whenever required.

. Responsible for preparation of response (compliance report) to various

regulatory and customer audit observations and sending the compliance

report to the respective auditing agency.

. Preparation of the internal audit schedule and coordinated with the

team for self-inspection.

. Preparation of observation and compliance report for improvement in

quality System

. Peparation of batch manufacturing records (BMR), batch packing records

(BPR) and SOP's.

. Reviewed BMR, BPR and test reports from QC and timely release of

batches for distribution

. Annual product quality review reports preparation

. Responsible for preparation, execution of validation protocols and

preparation of validation reports

. Imparted training to subordinates on cGMP topics as well as on job

SOPs training to comply the training schedule and calendar.

. Assisted department head in developing Systems, SOPs and documents as

per GMP requirements

. Product failure investigation, compilation of investigation reports

and related documents for their closure with prescribed documentation

. Root cause analysis of quality related issue and implementation of

CAPA (Corrective and Preventive Action) through proper documentation

. Investigation of market complaint, preparing the response for the

complainant and closure of the market complaint through proper

documentation

. Evaluation and Closure of Deviation with proper documentation

. Evaluation and Closure of Change control with proper documentation

. Preparation of daily observation report by visiting different areas

and departments

. Periodic Monitoring of control samples and their documentation

Academic Project

. Preparation and characterization of amorphous nanoparticles for

solubility and bioavailability enhancement

Research poster presented at conference

. Preparation and characterization of amorphous nanoparticles for

solubility enhancement to be presented at Indo-US joint symposium on

nanomedicine: Prospect and challenges held at ICT Mumbai

. Nail drug delivery system to be presented at current trends in NDDS at

R.C.Patel Pharmaceutical education and research, Shirpur

Seminars and workshop attained

. Attended a National seminar on "Current Prospective in Pharmaceutical

Technology" organized at AISSMS College of Pharmacy, Pune

. Attended International seminar on "Nanomedicines: Prospects and

challenges" organized at ICT Mumbai

. Attended a seminar on "Recent trends in drug design" organized at

S.M.B.T college, Nashik

. Attended a University of Pune sponsored Seminar on "Preclinical Trials-

Current Scenario" organized at AISSMS College of pharmacy, Pune

Areas of interest

. Pharmaceutical Quality assurance

Achievements

. GPAT 2010 Qualified

. Winner at state level in painting competition

. Winner in drama in college level

Personal Assets

. Honesty

. Desire to learn new technologies

. Team working and team handling capability

. Can adapt with any environment quickly

Personal Information

Date of Birth : 20th July 1988

Gender : Female

Marital Status : Married

Nationality : Indian

Languages Known : English, Marathi and Hindi

Permanent address : 104- Trimurti, Asha construction

Dhatrak Phata,

Panchvati, Nashik- 422003

I do hereby declare that the above-furnished information is true to the

best of my knowledge and belief.

Place: Nashik

Date: 02/07 / 2014

(Pranjali V. Malode)



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