Prashant M. Kale +91-989*******

Pune

A result oriented professional total 13+ years’ experience in

Pharmaceutical and Life Science as Computer System Validation (CSV) consultant for GxP/Non GxP System, and Software Development Life Cycle – SDLC, CSA.

ad5ad0@r.postjobfree.com

PROFILE SUMMARY CORE COMPETENCIES

• As professional having about 13+ years of experience in Life Sciences industry with expertise on Computer Systems Validation and Regulatory IT Compliance.

• Having strong background in author of Validation Plans, Validation Report pCMA and review of validation documentations inclusive of the URS, FS, FRA, DS, CS, Test Scripts, Installation Qualification (IQ), Operation Qualification

(OQ), Performance Qualification (PQ) specifications, Test Plan, Test report.

• Professional experience in Validation Practices with a good understanding of GxP standards, 21 CFR Part 11, EU Annex 11 and GAMP5.

• Hands on experience in HP-ALM, JIRA, Team Track, Version1, IBM Rational clear case, SNOW, IT360, DAIRY, Trackwaise. HPLC and GC software’s like Open LAB EZChrom, ChemStation, EMPOWER, LIMS etc.

• Mentored the team for Quality, Compliance, and Good Documentation Practices.

• Driving organizational process, improvement initiatives.

• Involved in client communication and interaction with business users.

• Good working knowledge of Validation, Manual, Functional testing in diverse applications under Life Sciences domain.

Computer System Validation

GAMP5

21 CFR Part 11

Risk Assessment

Change Management

CAPA

Defect Management

Deviation Management

TECHNICAL SKILLS

Waterfall

Agile

MS Office

CAREER TIMELINE

CERTIFICATIONS & RECOGNITION

Infosys Internal Agile Certification

Infosys certified Domain consultant Life

science

Infosys internal INSTA Award winner

WORK EXPERIENCE Persistence Sys Hi Fi award winner, twice 1. Infosys Limited Senior Consultant – Project Quality Manager 13 July 2020 -Present Working as Senior consultant at Infosys for one of the topmost Pharmaceutical Organization. With client I am working as Project Quality manager. As PQM I am playing very important role for implementation of software’s in GxP environment key responsibilities are listed as below.

• Manage validated state of IT applications and define Quality Management Process.

• Responsible for end-to-end CSV process as per client SOP’s.

• Responsible for review and approve lifecycle documentation for CSV by maintaining the quality and security standards

• Validate the Deliverables for each phase of the SDLC to ensure the quality of the deliverables

• Participating in required forums, meeting to review quality and compliance of application

• Prepare application for audits / assessments and provide support during audits / assessments

• Contribute to application related corrective actions and remediation of identified gaps and risks during quality audits and reviews. Mentor team for Quality, Compliance, and Good Documentation Practices.

• Ensuring the process is followed as defined and in compliance. B.Pharm

Jun 2007

R. T. M.

Nagpur

University

Jul 2007-Jun

2008

Lecturer at

SVCP

Worora.

M. Pharm

Jun 2010

NMIMS

University,

Mumbai

May 2010-

Mar 2011,

ICPA Ltd,

Ankleshwar,

as RA

Mar-2011-

Apr-

2012.Panac

ea Biotech

Ltd,

Mumbai as

RA

May 2012-

Sep 2016,

Glenmark

Pharma. Ltd

Mumbai as

RO

Oct 2016-

Jul- 2020

Persistent

System

Ltd, Pune

as DL

Jul 2020

till date

in Infosys

as Senior

Consulta

nt

PROJECTS ACCOMPLISHED

• Ensuring defect management cycle followed correctly and complete analysis performed for it.

• Driving organizational activity ex. Candidate evaluation, department activities etc. 2. Persistent System Ltd. Domain Lead 03 Oct 2016 to 09 Jul 2020 Domain Lead (IT compliances)

Reporting to Product owner

Responsibilities:

• Perform Quality Risk Management and Computer System Validation.

• Preparation Validation summary report, SOP Management Log, Risk Assessment.

• Professional experience in Validation Practices with a good understanding of GxP (GMP, GLP and GCP) standards and 21 CFR Part 11.

• Hands on experience in Jira by atlassian, ChemStation, LIMS, ELN, Empowers, Team Track and IBM Rational clear case.

• Skillful knowledge of Change control and Defect management

• Review of Test scripts and RTM.

• Performing IQ, OQ and PQ for software.

• Defect, Incident, Deviation and change control reporting and tracking & impact assessment.

• Maintaining project related functional documents such as test cases, test plans and requirements.

• Perform Quality Risk Management and Computer System Validation. 3. Glenmark Pharmaceutical Ltd Mumbai Research Officer 02 May 2012 to 30 Sep 2016.

4. Panacea Biotech Ltd, Mumbai Research Associate

07 Mar 2011 to 27 Apr2012.

5. ICPA Health Products Ltd, Ankleshwar Research Associate 16 May-2010 to 05 Mar 2011.

6. Siddhivinayak College of Pharmacy, Worora. Lecturer 02 Jul 2007 to 25 Jun 2008.

In Infosys

Client: Novartis

Role: Project Quality Manager

Projects Handel:

o GxP- Application

o Non-GxP Application

o Mobile Application

o Integration Project

o ERP Project

o LIMS

Responsibilities:

• Preparation of Project documentation list as per classification provided by system.

• Preparation of life cycle document including validation plan, validation report and Project Control Maturity Assessment.

• Understand application/tool and its workflow and define the validation strategy and define validation deliverables.

• Review and approval of URS, FS, DS, IQ, OQ, PQ specification. (HP ALM)

• Approval of IQ, OQ results.

• Review and approval of tollgate for each phase of Project.

• Maintaining compliance status throughout project span.

• Maintaining SDLC deliverables into repository

In Persistent system

Project 1

Client: Agilent Technologies

Role: Domain Lead

Team Size: 4 members

Project Application: Functional and Integration of Open LAB CDS ChemStation Edition. Description: OpenLAB CDS ChemStation Edition provides chromatography data acquisition, processing and control of GC and LC chromatographs and is used in chromatography operations ranging from single user/single instrument to multi-user/multi- instrument laboratories throughout the world. Supporting over 330 chromatograph modules from over 25 different manufacturers, OpenLAB CDS provides a unified computing strategy for the laboratory, so that users can work with a variety of instruments through a uniform user interface.

Responsibilities:

• Reviewing and preparing Validation documents like Requirement Specification Documents Validation Plans, Test scripts and Validation summary report.

• Delivered Validation and test document as per GxP guidelines and with highest customer satisfaction.

• Creating test planning, test cases, and test bed for system testing of application on different platforms.

• Responsible for requirement gathering and developing test plan for the test team.

• Involved in client discussions to gather the business requirements and to provide updates.

• Good knowledge about the GAMP 5 and electronic record maintenance and electronic signature. Project 2

Client: Agilent Technologies

Role: Domain Lead

Team Size: 4 members

Project Application: Functional and Integration Testing OpenLAB ELN Description: OpenLAB Electronic Lab Notebook (ELN) is a powerful, lab productivity application. Speed up your lab’ s cycle times with OpenLAB ELN — the central hub for organizing & sharing information across your entire laboratory. Record a video of a color change during a chemical reaction, take pictures of a whiteboard after a meeting, set multiple reminders (timers) when you’re in the midst of a time-sensitive experiment at the bench, or jot down a quick thought or idea when you’re on the go all from within one, centralized application: OpenLAB ELN. Responsibilities:

• Experience into the project documentation including creating MRD (Market Requirement Document), Functional Specification document and Test plan creation.

• Defect management and review.

• Maintaining project documents repository in IBM Rational Clear case.

• Handling client call for requirement gathering and status reporting.

• Providing knowledge transfer sessions for new joiners and team members.

• Providing domain knowledge trainings for other team members from business perspective.

• Handling team management activities including allocation of work and metrics preparation

• SOP preparation & Training to the users

• Good knowledge about the GAMP and electronic record maintenance and electronic signature EDUCATION

• Master of Pharmacy (JUNE 2010), NMIMS University, Mumbai.

• Bachelor of Pharmacy (JUNE 2007), R. T. M. Nagpur University, Nagpur.

• Diploma of Pharmacy (JUNE 2002), M.S.B.T.E, Mumbai. PERSONAL

Date of Birth : 16th January 1983

Gender : Male

Nationality : Indian

Marital status : Married

Languages known : English, Hindi & Marathi.

Address : Flat no Crest 904, Joyville, off Maan village road. Near Hinjewadi Phase 1. Pune 411057

Date: 02 Apr 2024 Yours Sincerely

Place: Pune Prashant M. Kale

“Thanks for Your Time”

Contact this candidate