Navi Mumbai 400 708
Contact No: 720-***-****
I seek to contribute to the growth of your organization, along with professional advancement and excellence in the field of Quality Assurance & Control department.
B.Sc from CALICUT UNIVERCITY.
Approved by FDA, Maharashtra in Chemical and Instrumentation
Also approved by FDA, Maharashtra in Microbiology and Sterility and in
Pyrogen and Toxicity.
Operating System:-MS DOS, Window XP 2000, Internet.
Office Tool : - MS Office (MS Word, Excel)
I have more than 29 years experience in the field of Quality Assurance & control of Drugs and pharmaceuticals.(Both API &Formulations)
Presently working in Agio pharmaceuticals Ltd as CQA manager from April 2019 on wards
Worked as a QC/QA manager in USFDA API COPMPANY AT Taloja for more than one year from August 16, 2017 to April 2019
Worked in Kremoint Pharma Pvt. Ltd. As a QC Manager 8 years:
(March 02.2009 to August 07,2017)
Professional Experience in formulation & R and D Company at Mahape
Worked with CRO based Company in Analytical Department as a Scientist (2nd October 2006-28th Feb 2009).
Professional Experience in Pharmaceuticals Company as a QC Manager in M/s Kilitch Drugs India Ltd for 5 years. Pawane New Mumbai
(July 2001-30 Sept 2006)
Worked as a Senior QC Officer in Kilitch Drugs India Ltd for 4 years.(July1997 -July 2001)
Worked as a Senior Quality Control Chemist in Pivotal Remides for One and Half Year. ( -November1995 -July1997)
Worked as a Quality Control Chemist in Ethical laboratories for One year.
Worked as an analytical Chemist in ANA laboratories for three and half years. (July1991-December 1994)
To manage overall activities of Quality Control Quality assurance Dept.
Release of RM/ /PM/. FP
Co- ordination with customers
Vendor Audit /self inspection.
Qualifications of equipments IQ/OQ/PQ.
Checking of BMR / BPR / Review of BMR.
Validation of Manufacturing process .
Preparation of Annual Product Quality Review
Investigation of Customer Complaint
Approval of Art work.
Preparation of STPs & SOPs
Change Control /Deviation Control
Routine Analytical work, stability studies, Raw material testing
Dissolution Testing and Instrumental analysis.
Day to day monitoring of Microbiology Laboratory
Co-ordination with QC for Stability studies
Analysis of Microbiological Assay and various Microbiological Technique.
Analysis of Pyrogen and Toxicity.
Various Microbiological techniques including Antibiotic Assay, Sterility,swab test PET etc
QA Activities as per ICH Guidelines :
Protocols Approvals for various Validations
Risk Assessment study on failure, deviation and Change control
Regulatory and Customer audits : Compliance with CAPA
QMS implementation : Handling of Laboratory failure, OOS and incidents
Data Integrity : Complying with 21 CFR Part II, Audit trail
Training on GMP / ICH guidelines to supporting staff
Vendor approval for KSMs and Vendor audits
QA: QMS System reviewing, BMR & BPR reviewing, training to concerned staff,
Cleaning validation PV & Vendor Audit.
QC: Training to QC Staff,STP reviewing,Trouble shooting related to QC & microbiology work
Regulatory: Reviewing of Documents related to QC & QA,AMV Protocol,Reports &query handling related to QA&QC
Audit Faced: WHO, Nigeria, Guana, Liberia, Uganda, Ethopia, Sierra Leone, Kenya, Philippines’
Analytical Instruments Handled :
HPLC: SHIMADZU, AGILENT, WATERS & JASCO.,
UV – VISIBLE SPECTROPHOTOMETER 1800 : SHIMADZU.
FOURIER TRANSFORM IR SPECTOPHOTOMETER
DISSOLUTION APPARATUS : ELECTROLAB.
Validation Studies : Dissolution test method validation, Non compendial,Assay method validation & Related substances analytical method validation..
Process validation and Cleaning validation
Date of Birth : 15th MAY 1968.
Sex : Female.
Marital status : Married.
Languages Known : English, Hindi .Marathi and Malayalam
Place : Airoli
Salary (CTC) : 8.50Lakh
Expected : Negotiable
Notice Period : 15 days to One month