Ganeshrao Dahatonde

Mob.No.+91-942*******

+91-932*******

adjyop@r.postjobfree.com

adjyop@r.postjobfree.com

Skype- ganeshrao.dahatonde

Address: New Mumbai

Qualification: M. Pharma QA

Working Experience: 12 Years

Department: Pharmaceutical Quality Assurance

Audit Exposure:

USFDA(5),MHRA(3),ANVISA(2),WHO,UGANDA,PERU,MEXICO,KENYA,CDSCO

Area Of work:

Audit and compliance, Internal and External Audit, Vendor audit and Management, CAPA,

Internal Audit, Training.

Area of interest to work

Audit and compliance, Corporate Quality Assurance

Achievement:

Successfully prepared and pass USFDA Audits.

Implementation of corporate CAPA within target timelines and always first for the same.

Represented site during Russia virtual Audit and received certification.

Career Objective: Adept working in fast-paced regulatory environments, demanding Quality of Product. Looking for a company, which will challenge my problem solving skills and allow me to continue to develop my knowledge and potential.

Academic Profile:

M. Pharm in Quality Assurance.(2006-2008)

Annamalai University, Chidambaram, Tamilnadu India.

B. Pharm (2000-2005)

Sudhakarrao Naik Institute of pharmacy, Pusad, Dist. Yavatmal, Amravati University.

Professional Summary:

Quality assurance professional with more than 12 years of experience in the pharmaceutical industry in sterile and non-sterile formulation (Injectable, Eye/ear drops, Oral Liquid, Oral & External Powder, Tablets and Capsules) and Sterile and Non sterile API.

Expert in audit and compliance, Vendor audit and Management, Handling of internal and external audit, Quality management systems, In process quality assurance, Failure investigation, Market complaint investigation etc.

Work Experience:

1)MJ Biopharm Pvt. Ltd. Navi Mumbai.

Start Date: February -2019

2)Pfizer Healthcare India pvt. Ltd, Aurangabad-Maharashtra”

Start Date :June-2015 to

End Date: February -2019

3)Wockhardt Ltd, H-14/2 MIDC Waluj Aurangabad-Maharashtra”

Start Date: August 2010

End Date: May 2015

4)Ajanta Pharma Paithan MIDC, Aurangabad-Maharashtra”

Start Date: December 2009

End Date: August 2010

5)FDC Limited Waluj MIDC, Aurangabad-Maharashtra”

Start Date: May 2008

End Date: December 2009

Key Responsibilities:

1)MJ Biopharm Pvt Ltd. (February 2019---)

Expert in Monitoring of biological Injectable product manufacturing Such as Insulin, Glargine etc.

Preparation of the site for the Audit.

Preparation of the audit response and complete tracking and drive of the compliance activity as per the timelines.

Preparation of the site master file.

Preparation, review and approval of master documents at site.

Vendor qualification as per the requirement.

Management quality review meeting.

Independently responsible for the QMS activity i.e. Change control, Deviations, CAPA, Market complaints, Out of specification (OOS).

Review and approval of the APQR.

Responsible for the site training management.

Batch release in market.

Investigation and risk assessment.

Responsible for the QC laboratory quality assurance activity.

Responsible for In process Quality Assurance.

Presentation of the quality matter to management during management quality review meeting.

Co-ordination with Regulatory and R& D for the introduction of new product at site.

2)Pfizer Healthcare India Pvt.Ltd. Sr.Executive QA (June-2015 to February 2019)

Preparation and training of SOP's related to Quality Assurance.

Preparation of SOGT (Structured on job training) training material based on high risk categorization.

CGMP certified trainer by Pfizer.

Certified internal auditor by Pfizer.

Qualification of new recruit for the MQA activity.

Monitoring of gowning qualification programme at site.

Certified for qualification of visual inspector for inspection of cleanliness of equipment.

Audit trail review for critical type -3 equipment. User access and audit trail management.

Data integrity assessment.

Process mapping for identification of procedural GAPs.

Active participation and monitoring of aseptic media fill simulation.

In process quality assurance for sterile and non-sterile manufacturing plant.

Verification of regulatory compliance and strict adherence to same.

Human error assessment (Learning, Omission, Application, Inconsistency and Decision),CAPA evaluation and monitoring.

Responsible for the audit trail review as per 21 CFR requirement.

Investigation by applying DMAIC six-sigma method -1 tool. Completed Yellow belt Certification.

Review of validation protocol and reports such as SIP Validation,SHS /DHS validation,Deadleg identification and removal,Boroscopy of the WFI,PWS and process pipeline.

Change control initiation and closeout.

Categoriwise trending of the observations and identification of the improvement area.

Preparation and participation in mock audit/Dry run.

To review the actual practices and ensure compliance of all the SOPs along with the related documents/ records.

Taking Facility walk through rounds of manufacturing facilities to ensure the cGMP compliance as per regulatory requirements.

Provide support during regulatory inspection, third party audit and consultants visits.

Timely and immediate escalation to senior management in case of deviations observed from the cGMP requirements.

3)Wockhardt Biotech Ltd, Executive QA (August 2010 to May 2015 )

Audit and compliance activity.

Co-ordination and guidance to functional head for proper implementation and timely closure of CAPA.

Surprise audit of production site for verification of effectiveness of CAPA.

Preparation of draft/final response to regulatory observation.

Verification of activity as per regulatory compliance.

Tracking of logged CAPA and verification of GAPs in system.

Status Updation of open/closed CAPA to senior management.

Facilitate the CAPA Process at sites

Analyze CAPA data for the respective sites.

In process Quality Assurance for Vial, cartridge and PFS.

Cold chain monitoring in that shipper and transport validation.

Notification to management.

4)Ajanta Pharmaceutical Paithan Officer QA (December 2009 to August 2010)

In Process Quality assurance, or IPQA.

Process validation sampling in Tablets dosage form.

Batch records review.

5)FDC Pharmaceutical Limited Waluj MIDC, Officer QA (May 2008 to December 2009)

Preparation of batch manufacturing records and batch packaging records.

Batch records review and release of batch.

Preparation of annual product quality review.

Change control issuance, follow-up and closing.

SOP issuance and retrieval of control copies.

QMS approval follow –up and closing.

Visit to loan license site for manufacturing of batches as per plan.

FDA licensing.

In Process Quality assurance, or IPQA for Ophthalmic dosage form, liquid dosage form and powder dosage form.

Computer proficiency and system knowledge:

MS-Office (Word, excel, PowerPoint etc.)

SAP

Trackwise

PLS

ProjectsDissertation Title

“Process validation of solid dosage form - Tablet”

An Eight months project work done at NuLife Pharmaceuticals Ltd., MIDC Bhosari, Pune.

Training programme

Attended “2013 PDA India chapter” at Mumbai.

Participation in training conducted by Parexel on “Aseptic practices and clean room behavior.”

Abilities and skills

Good Knowledge of Manufacturing Process and ability to maintain high Quality.

Able to implement Quality Assurance Procedures as per Harmonized Guidelines.

Experience in direct interactions with regulatory Inspectorate during site inspections.

Excellent communication skill. Time and team management.

Personal Information:

Date of Birth : 10thJanuary 1980

Father’s Name : Mr. A.K.Dahatonde

Marital status : Married

Religion : Hindu

Permanent Address : At Post Bibi, Ta.Lonar,Dist. Buldana, Maharashtra

Passport No. : N9471191

Languages Known : English, Hindi and Marathi (Read, Speak & Write)

Declaration:

I do here by declare that the information furnished above is true and complete to the best of my knowledge and belief.

Place: Aurangabad

Yours Truly,

Date:

(Ganeshrao Dahatonde)

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