Resume

Sapna Devi

adg3zi@r.postjobfree.com

+91-780*******, +91-830*******

CAREER OBJECTIVE

To Learn & grow as an individual and serve the organization to the best of my abilities & to gain practical exposure and become professionally trained to handle situations & Challenging responsibilities.

ORGANIZATIONAL EXPERIENCE

Dr. Reddys labs ltd. / Sep.2011–Present.

Total experience- 9 Years.

Working as a Microbiologist in Quality control department with the responsibilities of document review, validation, qualification.

FDA Approved chemist in Quality control, LSSSDC Certified & Certified Trainer.

JOB PROFILE & CORE RESPONSIBILITIES

Stakeholder Responsibilities

Preparation & review of Viable & non-viable environmental monitoring documents.

Handling of incidents, OOS, CAPA, risk assessment, Change control and related activities & conduct laboratory investigation.

Responsible as a second line to highlight & handle all quality and safety related issues in absence and presence of manager. And provide supports to solve the issues of classified areas & unities.

Review and coordinate for all method transfer, method validation & method verification activities of Finish Products and Raw materials.

Mentor & supervise to all microbiologist regarding microbiology tests & coordinate scheduling to maximize productivity.

Responsible for Performing validation & Performance verification, IQ/OQ of lab equipment/instruments & Calibration and preventive maintenance in Microbiology Lab (Internal & external).

Review and approve of all microbiological analytical test reports, logbooks of microbiology lab.

Review and preparation of trends reports related to Environmental monitoring and water.

Department Training coordinator for LMS (Learning management system) - ensure qualification of new analyst, training on procedures and other whatever required.

Protocols Preparation and review. ROA preparation, catalog preparation of Raw Material & Finish products.

Promote Data integrity culture in microbiology lab.

Participation during audits- to provide necessary support and explanation as per auditor’s requirement.

Microbiology operational Skills

Write,review & revise laboratory procedures.

Perform data analysis, data compilation and prepares results for review as per requirement.

Data review & trending to ensure integrity & adherence to Standard opertaing procedure & cGMPs.

Support daily collection of all types of samples. Compendia of testing such as Microbial limit test, Growth Promotion, endotoxin, conductivity and TOC and all chemical test of water.

Preparation, Sterilization and of Media and reagent used in Microbiology.

Revival, maintenance, Disposal of microbial Cultures.

Isolation, gram staining and microbial Identification of environmental & water isolates by VITEK 2 system.

Microbial Enumerations Test & maintenance of biological indicators & perform Disinfactant Efficacy tests..

Support audits as a Subject matter expert.

Analysis of different type of water used in pharmaceuticals.

Knowledge of Bacterial endotoxin test.

Knowledge of Sterility test.

Extra activities:

Improvement projects on removal of performance validation of discarding autoclave with external sensors, Project on Catalog preparation of 52 products across our unit.

In safety: Worked as a safety star cap having LOTO Knowledge

Responsible for Near miss, unsafe condition and unsafe act CAPA closure.

Certified first aider from Safety Circle.

SOI auditor- To conduct SOI audit and comply all CAPA.

Responsible for organizing time to time Get together activities like annual day Celebrations, sports activities etc.

IT& instrument knowledge:

Having good knowledge of MS OFFICE.

Software knowledge- SAP, DOCHUB, Isolate, iCreate.

Instrument knowledge- VITEK 2, Autoclave, BOD incubators, LAF, Pass box, Microscope, TOC, Conductivity meter, balances, colony counter.

ACADEMIC DETAILS

Qualification

Board/university

Marks Obtained

M.Sc. in Microbiology

Desh Bhagat University

Pursuing

B.Sc. in Pharmaceutical chemistry

Chitkara university, RAJPURA

80%

12th Medical

H.P Board

74%

10th

H.P Board

84%

PERSONAL DETAILS

Father’s Name : Sh. Salig Ram

Address : At-Village Chaksar, P.O. Hatli, Teh. Bangana, Distt. Una Himachal Pradesh.

Date of Birth : 30-11-1992

Marital Status : Unmarried

Nationality : Indian

Language known : English and Hindi

DECLARATION

I hereby declare that all the information given above is true to the best of my knowledge.

SAPNA DEVI

Contact this candidate