RESUME

SREEJA PRAKASH

B*/*:* Swarajya Apartment,

Sector-10, Airoli

Navi Mumbai 400 708

Contact No: 720-***-****

Email: ado3ps@r.postjobfree.com.

OBJECTIVE

I seek to contribute to the growth of your organization, along with professional advancement and excellence in the field of Quality Assurance & Control department.

ACADEMIC QUALIFICATION:

B.Sc from CALICUT UNIVERCITY.

ADDITIONAL QUALIFICATIONS:

Approved by FDA, Maharashtra in Chemical and Instrumentation

Also approved by FDA, Maharashtra in Microbiology and Sterility and in

Pyrogen and Toxicity.

Computer Knowledge.

Operating System:-MS DOS, Window XP 2000, Internet.

Office Tool : - MS Office (MS Word, Excel)

Experience :

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.

(Jan-1995-Oct-1995)

Worked as an analytical Chemist in ANA laboratories for three and half years. (July1991-December 1994)

Job Responsibility:-

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

BET Test

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

CQA: RESPONSIBILITY:

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

:PERSONAL DETAILS:

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

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