BHUVNESWAR

SARASWAT

ASSISTANT MANAGER QC QA

PERSONAL INFO

+91-897*******

adoau7@r.postjobfree.com

**/***- ****** ***** ********* Laxminagar, Mathura Uttar Pradesh-281001.

SUMMARY

Quality professional with 10 years of progressive experience in pharmaceutical formulation (Injectable, Lyophilize, Oral solid dosage, derma) industry with sound knowledge in QC, QA and analytical method validation/method transfer. Expertise in product non-conformance investigations (OOS/OOT/incident), compliance, Team Leading, QMS, Green-field project, CSV, change management, analytical document review,

internal/external audits and quality document management. Excellent management skills, hands on experience in handling QC analytical instruments (HPLC, Dissolution, Disintegration Tester, IR, UV etc.).

SKILLS

Team Leading

QMS

OOS, OOT, Incident

Investigations

Change management

Green-field

project

Computerized System

Validation

Method Transfer/ Method

Validation

EXPERIENCE

ASSISTANT MANAGER QC QA

Alembic Pharmaceuticals Group - Aleor Ltd

(Dec 2017 -

Current)

Monitoring of cGMP/GLP practices followed during routine operation to ensure adherence of procedure.

Investigation of OOS/OOT/Incidence. Participate in brain storming for the design of hypothesis study and trouble shooting.

Change control management and monitoring of the

implementation of changes as per change control.

Review of analytical data of IP/FP, Stability, RM /PM. Review of analytical Method validation protocol/analytical data/reports.

Review and Approval Specification/Standard testing procedure/Test data sheet.

Preparation/Review of Standard Operating Procedures as per requirement.

Review of Stability Study protocol and monthly stability samples withdrawal plan, Monitoring of the daily activity of chambers.

Instrument qualification and computerized system validation

(CSV) as per CFR part 11 and GAMP-5 requirement in GMP laboratory.

Actively participated in various regulatory audits like USFDA, MHRA, WHO etc. and part of compliance response team. SENIOR TEAM MEMBER –QC

Dr. Reddy's Laboratories

(May 2016 -

Dec 2017)

Review of analytical data of IP/FP, Stability, RM /PM. Investigation of OOS/OOT/Incidence.

Change control preparation and implementation of changes as per change control.

Preparation of Standard Operating Procedures as per requirement.

Preparation of Specification/Standard testing procedure/Test data sheet.

Preparation of stability study protocol and stability summary sheet.

Instrument qualification and computerized system validation

(CSV) as per CFR part 11 and GAMP-5 requirement in GMP laboratory.

ASST. IN CHARGE QC

DSM Sinochem Pharmaceuticals

(Sep 2015 -

May 2016)

Preparation of Specification/ analytical test procedure/ test data sheet.

Initiating the Change control and preparation of document as per change control.

Preparation of Method validation /method transfer protocol and report.

Performing the Method validation and method transfer activity. Analysis of Finished /stability Product and raw material. Preparation of stability study protocol and charging and withdrawal of samples.

OFFICER- QC

Lupin Pharmaceuticals

(Jan 2013 -

Sep 2015)

Analysis of Finished Product, Stability Product (tablet, Capsule), cleaning samples and preparation of analytical data. Regulatory Audit, USFDA,

MHRA, etc.

Risk Management.

LANGUAGES

English

Hindi

Performing the Method validation and method transfer activity. Calibration of Instruments

Participate in OOS and OOT investigation

Documentation as per GDP.

JR.OFFICER- QC

Sharon Bio-Medicine Ltd. Dehradun

(Aug 2011 -

Dec 2012)

Sampling of Raw/Packaging Material.

Analysis of Raw/Packaging Material Analysis.

Calibration of Instruments.

Participate in OOS and OOT investigation

Documentation as per GDP.

PROJECTS

Green Field project-Computerized System

Validation (Dec 2017 - Current)

Chromeleon 7.2

Stability Sample Management Software Version: V2.0.0, Developed by Tangent tech.

iXLc Software Version 2.3.1.0 Developed by IVYWORKS Advisors LLP.

Stability Control software by Thermolab Scientific. COTS Software.

Patch Updation.

EDUCATION

M.SC.(PHARMACEUTICAL

CHEMISTRY) - 62%

H.N.B. Garhwal Central University.

(Jul 2009 -

Jun 2011)

B.Sc.(Biotechnology) - 75%

J.N.R. RAJASTHAN VIDHYAPEETH UNIVERSITY.

(Jul 2005 -

Jun 2008)

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