Quality Assurance Expert with Over 10 Years Experience
1. GHULE SAROJINI SAGAR M.Pharm (Pharmacognosy)
ORGANISATIONAL EXPERIENCE
Name of Organisation: SGPharma Pvt. Ltd.
Designation - Quality Assurance - Officer
From: February 2015 till date
Job Responsibilities
1. Preparation of Raw material and Finished Product Specification.
2. Preparation of Process Validation Protocol.
3. Review of report of stability study, finished product and raw material
4. Checking of Analytical Method Validation Reports.
5. Checking Batch Manufacturing Records.
6. Master Formula Record Checking and Approval
7. Handling deviation & Change Control.
8. Checking of licence and draft label.
9. Preparation of product information file.
10. Visit to factory for FPQC.
Name of Organisation: Meyer Organics Pvt. Ltd.
Designation - Quality Assurance - Officer
From: August 2013 to February 2015
Job Responsibilities
1. Aware of Q.A documentation Since initial set up of the plant till commercial production and WHO GMP certified which
includes qualification (URS/DQ/IQ/OQ/PQ), AQP, VMP, SMF.
2. AHU and water system validation.
3. Checking Control Sample of Loan License Party
4. BMR Preparation, revision and verification
5. Release of finished products to despatch.
6. IPQC of tablet Capsule.
7. Handling of HPLC, FT-IR, UV – VIS Spectrophotometer
8. MIS Report and QA Report preparation every month.
9. Calibration of equipment
10. Aware of deviation change control OOS, complaint report.
Name of Organisation: Sanpras Healthcare Pvt. Ltd
Designation - Quality Control Officer
From: July 2011 to June 2013
Job Responsibilities
❒ Aware with analytical method development and validation of finished product and raw material.
❒ Preparation of TDS, specification of raw material, finished product.
❒ Analysis of RM/FP/PM
❒ Proficient in microbiological area- TBC, TFC, pathogen detection.
❒ Review of analytical data and having proficiency in Handling of HPLC, FT-IR, UV – VIS Spectrophotometer.
❒ Aware of Q.A documentation Since initial set up of the plant till commercial production and WHO GMP certified which
includes, AQP, VMP, SMF, AHU and water system validation, process validation, stability protocols as per latest ICH
guideline and all the routine documents as per WHO GMP guideline, MFR/BMR and all documents control of the QA
department.
ACADEMICS RECORD
Course University/Board Year of Passing Percentage Class
M.Pharm Pune June 2011 72.21 First class with Distinction
B.Pharm Pune May 2009 65.25 First class
H.S.C Pune Feb 2004 66.17 First class
S.S.C Pune Mar 2002 75.06 First Class with Distinction
2. ORGANISATIONAL TRAINING
❒Undergone one month training in SciTech laboratories Pvt. Ltd.
M.PHARM DISSERTATION WORK
Project Title
To study preparation and evaluation of phyto-phospholipid complex of gymnemic acid for antidiabetic activity.
CONFERENCE/ WORKSHOP ATTENDED
❒ Actively participation in workshop on recent methods of herbal drug analysis.
❒ Actively participation national conference on advances in phytochemistry and pharmacognosy.
COMPUTER PROFICIENCY
❒ Windows operating systems and application software like Microsoft Office package.
❒ Knowledge of software like ERP, Chem. Draw.
AWARDS / ACHIEVEMENT
1) GATE 2009 (90.34)
2) National Level Talent Pharma Search Examination (54th rank).
3) WHO audit face
4) FDA approval in microbiology section.
PERSONAL PROFILE
Name : Sarojini Sagar Ghule
Date of birth : 25th Aug.1986
Sex : Female
Marital Status : Married
Nationality : Indian
Languages Known : English, Hindi , Marathi
Contact No. : 09423132881 - 0251 – 2272001 mail id- mutkulesarojini@gmail.com
Present Address: : Ashirwad Nivas, Phule Nagar, At post:- Mohone, Tal:- Kalyan, Dist:- Thane (421102).
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