Mrs. Sheela Sharma
FLAT NO. 48
TRILOKIYA ADARSH APARTMENT
I.P. EXTN. PLOT NO. - 85
NEW DELHI –110092
E-mail c_ firstname.lastname@example.org, email@example.com
Mobile –+919899462317 (NEW DELHI)
( SPOUSE ADDRESS IN UAE AJMAN )
KHK SCAFFOLDING AND FORMWORKS L.L.C
POST BOX 2701
UNITED ARAB EMIRATES
E-mail c_ firstname.lastname@example.org GSM - 00971-50-4815980
Experience in Quality Assurance / Quality Control / Regulatory Affairs
Seeking management position in the area of QC/QA/R&D / Regulatory Affairs with a challenging and
responsible position with opportunity for advancement of potential, where my knowledge and experience will
enhance productivity and effectiveness of the organization.
A M.Pharma Over 06 years of experience in Quality control /Quality Assurance / Regulatory Affairs in
Handled instruments such as GC, HPLC, UV- Visible Spectrophotometer, FTIR, Potentiometer, Karl fisher titrator, Coulometer, Melting point apparatus, Polarimeter, Bulk density tester, Viscometer, Friability test
apparatus, Disintegration test apparatus, Dissolution test apparatus, IR moisture analyzer, Refractometer, PH
meter, Analytical balance.
1. SSC St. Francis Xavier’s High school, Goa 1992. (With Distinction)
2. HSSC St. Xavier’s Higher Secondary School, Goa, 1994. (With First Class)
3. B.PHARM, College of pharmacy, Goa 1998. (With First Class)
4. M.PHARM (QUALITY ASSURANCE), College of pharmacy, Goa 2000. (First Class with
ACHIEVMENTS / PROJECTS
GATE Score’ year 1998 – with 94.6 Percentile.
FDA approved in chemical and instrumental section.
Associated Member of Pharmacy Council of India
Project work on “Cleaning validation of coating and closed product conveying systems in an
automated granules manufacturing plant” at German Remedies Ltd. Goa
?S WORD, EXCEL, POWER POINT, INTERNET?
SYNMEDIC LABORATORIES, NEW DELHI
SEPT' 2005 TILL TO DATE
REGULATORY AFFAIRS OFFICER
1. Review master documents for regulatory submission.
2. Generation of product dossiers for CIS countries, South Asian countries and African countries.
3. Liasoned with the local FDA for requisite regulatory / statutory compliances.
4. Co-ordination with Medical/Research institutes for conduction of Bio-equivalence studies as per GCP
5. To establish Quality Systems for the Factory (API manufacturing) & Research Center (Contract Research,
Custom Synthesis, Scale-up, Pilot, low volume API facilities) to meet international regulatory requirements.
6. To support & provide all the necessary regulatory registration documents (DMFs etc) to enable the Company
to establish in “regulated markets ”. 7. Well versed with the contemporary international as well as national regulatory requirements such as UK-
MHRA, US-FDA,TGA-Australia,ICH,WHO-GMP and Schedule M. Ensured confirmation to all Quality
certification requirements and adherence in continuum.
8. To collect, review, compile & prepare quality data towards DMF & Dossier requirements as per international
9. Periodical internal self-Auditing of the API plant, Research center & external auditing of raw & packing
materials, towards compliance, - everything concerned to the quality of product entering into regulatory markets
to match the international regulations / standards & strict requirements.
10. Generated documents as per the requirements of current good manufacturing practices for different
Regulatory audits. Carried out internal GMP, Facility and documentation audits.
BRAWN LABORATORIES (FARIDABAD) HARYANA JUNE' 2005 – till to date
MANAGER (QUALITY ASSURANCE / QUALITY CONTROL)
1. Well verse with pharmacopoieal standards of USP, BP, IP, cGMP and GLP.
2. Handle approval of Products for the Brawn Laboratories
3. Ensure adherence to specifications of finished products through quality testing based on chemical and
Instrumental and microbiological parameters.
4. Develop & implement SOPs to enable conformance with predefined standards
5. Prepare Technical Dossiers of Tablets, Capsules, Parenterals, Liquid orals, Ointment of Brawn laboratories
Laboratories in Middle East, Europe, Myanmar and Brazil.
Process Development & Validation
Develop & validate methods for analysis.
Monitor processes for manufacture and quality of products.
Render technical and analytical support to Domestic & International Marketing teams. Conduct training programs for Analysts.
Handle recruitment & training of personnel.
Mentor and motivate teams to optimise their contribution levels.
Handling of various section of chemical, instrumental, microbiological and quality assurance department.
1. Checking of analytical reports of raw materials and finished products. 2. Checking of calibration records of HPLC, UV-spectrophotometer, and FTIR, Dissolution test apparatus
Karl Fisher apparatus, Potentiometer, Polarimeter and other instruments.
3. Checking of working standard protocols.
4. Checking of logbooks of different analytical instruments.
5. Checking of all QC documents.
CIPLA MEDEX SPECIALITIES PVT.LTD. GOA
MAY 2003 TO APRIL 2005
QUALITY CONTROL DEPARTMENT (SENIOR EXECUTIVE)
1. To Assist the QC Manager / Asst. QC Manager in the implementation of the groups Management system.
2. To provide advices and guidance’s to the management team and company personnel.
3. Monitoring and implementation of company specific plans.
4. Checking of analytical reports of raw materials and finished products.
5. Checking of calibration records of HPLC, UV-spectrophotometer, FTIR, Dissolution test apparatus, Karl Fisher apparatus, Potentiometer, Polarimeter and other instruments.
6. Checking of working standard protocols.
7. Performed qualification studies IQ/OQ/PQ of HPLC, UV-spectrophotometer, FTIR, Dissolution test apparatus, Karl Fisher apparatus, Potentiometer, Polarimeter and other instruments. 8. Checking of column performance data.
9. Performed internal audits for other units owned by CIPLA to check for compliance with cGMP, GLP. 10. Checking of logbooks of different analytical instruments.
11. Preparation of specifications for raw materials and finished goods.
12. Preparation of masters for test data sheets for raw materials and finished goods. 13. Raising indents (purchase orders) for columns, reagents and glassware.
14. Preparation of analytical method validation protocols.
15. Allotment of work for junior chemist.
16. Co-ordination with public laboratories for timely release.
17. Headed different section of raw material and finished goods.
II. SIGMA PHARMACEUTICALS LTD .GOA
MAY 2000 TO MAY 2003
QC / QA (JUNIOR CHEMIST)
(A) QUALITY CONTROL DEPARTMENT
1. Statistical sampling of raw material and finished goods.
2. Chemical & Instrumental analysis of potable water, purified water and water for injection. 3. Chemical and instrumental analysis of raw materials, intermediates, finished goods, validation Sample and Preparation of analytical reports of the same as per GLP.
4. Performed stability studies of injectables, tablets, liquid orals and capsules
5. Performed validation studies which included process validation, analytical method validation and cleaning validation.
6. Calibration of analytical instruments of GC, HPLC, FTIR, Karl Fisher apparatus, Dissolution test Apparatus, disintegration test apparatus, Refractometer, Polarimeter, Potentiometer, Friability test Apparatus, Glassware’s, Analytical Balance.
7. Preparation of test reagents, volumetric solution and its standardization.
8. Analysis of market complaint sample.
9. Preparation of working standards protocol.
(B) QUALITY ASSURANCE DEPARTMENT
1. Preparation of standard operating procedures and proper.
2. Ensuring proper authorization and control of SOP’s.
3. Preparation of validation protocols.
4. Identification and validation at all critical stages of process.
5. Preparation of process validation report.
6. Performed in process quality assurance checks for parenterals, tablet, liquid orals and capsule and line Clearance. It also included online documentation, ensuring adherence to written procedures, monitoring Yields and losses at all critical stages.
7. Conducted microbiological environmental monitoring in sterile room.
8. Issuing of batch manufacturing records (BMR’s) and checking of BMR’S.
9. Validation of autoclave and dry heat sterilizer.
10. Monitoring of temperature, humidity records of environmental chambers.
Languages known : Hindi, English , Marathi ,kokani
Hobbies : Reading News magazines and listening music.
Date of Birth : 21 Nov 1976
Husband Name : Mr. Chander Parkash