Aradhana Jayeshkumar Patel

Mobile : +1-905-***-**** Email : adrsdx@r.postjobfree.com

LinkedIn Brampton, Ontario

SUMMARY:

Having 10-year experience in various regulatory pharmaceutical organizations in Microbiology and QA department.

Participated in successful USFDA inspection for Microbiology section as Senior Microbiologist.

Well conversant with Windows, MS office- Word, Excel, Teams

TECHNICAL SKILLS:

Preparation and review of SOPs, STP Protocol, Analytical protocol, Validation protocol and report in Microbiology lab.

Analysis and review of Hold time study, swab test.

Validation activity performed for Water Validation.

Manufacturing area, Micro area, and Pass box qualification (By environmental monitoring)

Training to sub-ordinates for GLP, GMP and Microbiology laboratory practices.

Calibration of laboratory instruments &Equipment used for Microbiology lab i.e., analytical balance, pH meter, colony counter, BOD incubators, Autoclave etc.

Microbiological analysis of Purified Water, R O Water, Raw Water, Soft Water, Raw-Materials, Semi-Finished Products, Finish Products, Stability Sample, F&D Sample, Syrup and Suspension, BET test, Microbiological assay test.

Environmental Monitoring in manufacturing area & Microbiological laboratory and Pass box.

Culture transfer, Culture maintains and Growth promotion test like all activity.

Handling of Change control, Deviation, CAPA.

Maintain required documents and records.

The fumigation in Microbiological Laboratory departments.

Responsible for ensuring the compliance of plant activities through daily rounds.

Responsible for Preparation of Annual Product review (PQR).

Responsible for Preparation, review, and coordination for approval of SOPs.

Responsible for preparing Protocol and Report of compressed air, Nitrogen gas, Filter integrity tests HVAC qualification, LAF Qualification, Autoclave Qualification, Water Re-Validation, Temperature mapping related activities.

Responsible for preparation and review of Master Batch Manufacturing Records.

Responsible for assisting in investigations related to QMS related activities like change control, deviations etc.

Responsible to identify the areas for improvement with co-ordination with another department.

Responsible for any other work assigned by Department Head.

Responsible for Product sampling, packing, labelling, dispatch activity.

Responsible for Equipment and Instrument Calibration.

Responsible for review of executed BPCR.

PROFESSIONAL EXPERIENCE:

Synbiotics Limited – Vadodara, India March 2020 – Oct 2021

Sr. Officer Quality Assurance

Responsibilities:

Training to sub-ordinates for GLP, GMP.

Maintain required documents and records as per WHO-cGMP & USFDA certified.

Responsible for Change control, Deviation, CAPA & OOS.

Responsible for ensuring the compliance of plant activities through daily rounds.

Responsible for Preparation of Annual Product review (PQR).

Responsible for Preparation, review, and coordination for approval of SOPs.

Responsible for preparing Protocol and Report of compressed air, Nitrogen gas, Filter integrity tests HVAC qualification, LAF Qualification, Autoclave Qualification, Water Re-Validation, Temperature mapping related activities.

Responsible for Equipment and Instrument Calibration.

Responsible for preparation and review of Master Batch Manufacturing Records.

Responsible for assisting in investigations related to QMS related activities like change control, deviations etc.

Responsible to identify the areas for improvement with co-ordination with another department.

Responsible for any other work assigned by Department Head.

Responsible for Product sampling, packing, labelling, dispatch activity.

Responsible for review of executed BPCR.

Responsible for Document Management System.

Perform BET test and Microbiological assay test in micro lab.

DWD Pharmaceutical Limited – Vadodara, India Aug 2018 – Sep 2019

Executive Microbiologist

Responsibilities:

Equipment validation and calibration.

Maintain required documents and records as per WHO-cGMP

Responsible for Finish Product and Water sampling and labelling.

Microbiological analysis of Water Purified, RO, Raw Water, Raw-Materials & Semi- Finished product and Finish Products, Microbiological assay test.

Analysis and review of Hold time study and swab test.

Validation & Qualification activity performed for Autoclave qualification, Water Validation

Manufacturing area and Pass box qualification (By environmental monitoring)

Calibration of laboratory instruments &Equipment used for Microbiology lab i.e. analytical balance, pH meter, colony counter, BOD incubators, Autoclave etc.

Handling of Change control, Deviation, CAPA & OOS in Microbiology lab.

To monitor the fumigation in various department.

Plate exposure in various department for monitoring environmental hygienic condition and preparation of summary report.

Culture transfer, Culture maintains and Growth promotion test like all activity

Vovantis Laboratories Pvt. Limited – Vadodara, India July 2016 – Aug 2018

Sr. Microbiologist

Responsibilities:

Calibration of laboratory instruments & Equipment used for Microbiology lab i.e., analytical balance, pH meter, colony counter, BOD incubators, Autoclave etc.

Maintain required documents and records as per WHO-cGMP and USFDA.

Responsible for Finish Product and Water sampling and labelling and preparation of summary report.

Microbiological analysis of Purified, RO, Raw Water, Raw-Materials & Finish Products of Effervescent tablet and Sachet and Microbiological assay test.

To monitor the fumigation in various department.

Plate exposure in various department for monitoring environmental hygienic condition and preparation of summary report.

Participated in successful USFDA inspection for Microbiology section as Senior Microbiologist.

Culture transfer, Culture maintains and Growth promotion test like all activity

Terrene Pharma Private Limited – Vadodara, India June 2013 – June 2016

Microbiologist

Responsibilities:

Calibration of laboratory instruments &Equipment used for Microbiology lab i.e., analytical balance, pH meter, colony counter, BOD incubators, Autoclave etc.

Maintain required documents and records as per WHO-cGMP.

Responsible for Finish Product and Water sampling and labelling and preparation of summary report.

Microbiological analysis of Purified, RO, Raw Water, Raw-Materials & Finish Products of E.H.G. Capsules.

To monitor the fumigation in various department.

Plate exposure in various department for monitoring environmental hygienic condition and preparation of summary report.

Culture transfer, Culture maintains and Growth promotion test like all activity.

Hindustan Pharmachem Limited – Vadodara, India June 2008 – Jan 2010

Microbiologist

Responsibilities:

Calibration of laboratory instruments &Equipment used for Microbiology lab i.e., analytical balance, pH meter, colony counter, BOD incubators, Autoclave etc.

Maintain required documents and records as per WHO-cGMP.

Responsible for Finish Product and Water sampling and labelling and preparation of summary report.

Microbiological analysis of Water Purified, RO, Raw Water, Raw-Materials & Semi- Finished product and Finish Products.

To monitor the fumigation in various department.

Plate exposure in various department for monitoring environmental hygienic condition and preparation of summary report.

Culture transfer, Culture maintains and Growth promotion test like all activity.

Comed Chemicals Limited – Vadodara, India May 2007 – May 2008

Microbiologist

Responsibilities:

Calibration of laboratory instruments &Equipment used for Microbiology lab i.e., analytical balance, pH meter, colony counter, BOD incubators, Autoclave etc.

Maintain required documents and records as per WHO-cGMP.

Responsible for Finish Product and Water sampling and labelling and preparation of summary report.

Microbiological analysis of Water Purified, RO, Raw Water, Raw-Materials & Semi- Finished product and Finish Products and Microbiological assay test.

To monitor the fumigation in various department.

Plate exposure in various department for monitoring environmental hygienic condition and preparation of summary report.

Culture transfer, Culture maintains and Growth promotion test like all activity.

EDUCATION:

Degree

University/Board

Location

Year of Passing

M.SC. Microbiology

ICMT College, Vinayaka Missions University

Vadodara, India

Aug-2012

B.SC. Microbiology

M. B. Patel College, Sardar Patel University

Anand, India

Nov-2005

D.M.L.T.

Ambalal Sarabhai Foundation

Vadodara, India

Jan-2005

D.M.L.T. (Training)

Government of Gujarat, Gandhinagar

Vadodara, India

Aug-2004

HSC

Lal Bahadur School, Gujarat Secondary Education Board

Vadodara, India

July-2001

SSC

Nutan Vidyalaya, Gujarat Secondary Education Board

Vadodara, India

Mar-1999

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