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Quality assurance, Validation, customer complaint, CAPA

Location:
Dubai, United Arab Emirates
Posted:
June 03, 2021

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Resume:

AMRUT SATISH PARAB +971-*********

+91-816*******

admwxv@r.postjobfree.com

Profile: Quality Assurance Executive with total 6 years 06 months of experience. Relevant experience in Data Reviewer, QMS, Validation, Instrument/Equipment Calibration and Qualification, Batch Release, Routine analysis, Microbiology techniques, Biotechnology techniques, Stability study monitoring and Packaging artwork Skills:

Validation, Stability, Development, Working standard qualification and Method transfer data reviewer

QMS

APQR,PDR,BMR

Market complaint, Supplier quality complaint,

Calibration of Instrument's

Instruments / Equipment Qualification (Lab set-up)

Calibration and PM Report review

Licence: Test licence (Form 11 Application)

Molecular biology techniques

Training Program

Routine Analysis

Ensure e-data monitoring, access, data back up in the lab

Vendor Qualification

Very well versed with GLP environment (Compliance)

Audit: USFDA, ISO 9001:2015, ISO 22716:2007, MOH Experience:

Gulf Center Cosmetics Manufacturing LLC. Nov'2019-till date QA- Executive - Dubai

Akums Drugs & Pharmaceutical Ltd Jan’2018-Oct’2019 QA Officer (US and Europe Market)

Enem Nostrum Remedies Ltd May’2016-Jan’2018

QA Officer (US Market)

Method Validation, Development, Stability and Method Transfer Data review

Validation and Method transfer protocol/report review

Method and Specification Review

Deviation, Incident, CAPA,RCA

Handling Change control management

SOP Preparation/Drafting/Checking/Distribution and Retrieval

Issuance of Formats/Forms/BMR

Training Program

Stability Study Monitoring

Batch Release in ERP system

Audit trial: System audit trial, project audit trial

Project creation, User privileges, User login creation on Instruments

Packaging artwork review/approval in software.

Ajanta Pharma Ltd Oct’2014-Apr’2016

ADL Officer

HPLC: Calibration (openlab/Empower 3 software).

UV-Visible Spectrophotometer: Agilent technologies.

Dissolution Test Apparatus: Electrolab.

Disintegration Test Apparatus: Electrolab.

FTIR: Agilent Technologies.

Autotitrator: Moisture content by Kf.

Viscometer: Brookfield.

Osmometer: Advance instruments.

pH meter, Balance.

Biotechnology:

ELISA.

Western Blotting.

SDS Page.

Cancer Marker Screening.

Bio burden.

Molecular Biology Techniques.

Education: University of Mumbai 2012-2014

M.sc, Biotechnology - 67% (CGPA-A)

Viva College, Virar, Mumbai

University of Mumbai 2009-2012

B.sc, Biotechnology - 56%

Gogate Jogalekar College, Ratnagiri

Maharashtra State Board HSC 2007-2009

12th, Science - 61%

Dadasaheb Tirodkar Jr. College, Pandurtitha, Kudal Maharashtra State Board SSC 2006-2007

10th, 75%

Shivaji English School, Pandurtitha, Kudal

Personal Details:

Name: Amrut Satish Parab.

Date of Birth: 13/09/1991

Nationality: Indian.

Language Known: English, Marathi, Hindi.

Hobbies: Painting, drawing, playing Cricket

Strengths: Confident, Self-learner

Permanent address: F-802, Patel Elysium, Pale Gaon, Ambernath, East, Thane.

Present address: A-704, Loothah Building, Al Qasimia, Sharjah, UAE. Declaration: I hereby declare that the above written particulars are true to the best of my knowledge and belief.

Amrut Satish Parab



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