Pritam Pal
IT Services
Bengaluru
Summary
Seeking a rewarding position within a prestigious organization that provides ample growth opportunities and a stimulating work atmosphere to further develop skills and expertise. Eager to contribute talents and dedication towards achieving mutual success and advancement within a dynamic professional setting. Passionate about continuous learning and growth, committed to making a meaningful impact and excelling in a challenging work environment that fosters personal and professional development.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Consultant
Atos India Pvt Ltd
08.2022 - Current
- Responsible for independent evaluation of management systems and internal controls to provide reasonable assurance that they are working effectively and in compliance with laws and regulations as applicable. May relate to, for example, compliance to ISO standards, IT control framework and any contractual requirements, maturity assessment.
• Responsible to design, plan and implement organization's IT audit program (internal/external/client) with significant complexity adopting a risk based approached. Monitors the entire audit process and ensures it is carried out with high accuracy.
• Applies the organization’s audit methodology and carries out the audit procedures to meet the specific audit engagement objectives
• Creates audit engagement plans based on the risk and its impact on the organization
• Presents findings and proposes recommendations that deal with root cause of issues and impact to the organization
• Has expert knowledge in his/her field of specialization and works independently.
• Accountable for creating an enabling environment and takes decisions impacting the entire audit program. Accountable for successful execution of internal, external & client audit.
• Ensures the quality of planning and timely delivery of audit engagements
• Maintains industry specific knowledge appropriate to the organization & Basic technical knowledge on IT infrastructure
• Encourages others to propose innovative ideas and provides positive feedback to ensure new ideas are progressed
• Implements & participates within change programs across the audit function and team
• Ability to work with all levels of management
• Demonstrates efficiency and persistence, managing own time and ensuring engagement deadlines and objectives are met
• Demonstrates working knowledge of the quality control frameworks relevant to the audit engagements
• Ability to effectively communicate complex issues to management, both orally and in writing, in an accurate well-organized, logical manner
• Identifies the risks associated with change and adapts audit activity to manage the risks
• Contributes to insight and proposals for change and improvement
• Identifies and escalates the strategic implications to the organization from audit engagement findings
• Maintains constructive relationships with internal & external stakeholders
• Assesses self-development and career needs and takes advantage of new challenges as opportunities for personal and professional growth
• Ability to promote value of internal audits
•• Has strong Governance & ethics sensitivityenvironment to maintain the complaint status of the customer's environment. - Working as a internal auditor for SoX related reporting to customer.
- Handling SoX compliance audit ie. ISAE 3402, ISAE 3000.
- Familiar with DigiD Framework for Dutch Nationalized Bank, DNB Control Framework for Dutch National Bank, DORA, NIST.
- Responsible for carried out the end to end validation process for the computer systems like ERP systems (SAP QM module, Ms AZURE as a PASS components,)
CDYMAX India Pvt Ltd
01.2022 - 08.2022
- Followed Computer Systems Validation CSV Master Plan to author, review and approve CSV deliverables for systems as per GxP, GMP, GDP, cGMP FDA Assessment.
- Authored, reviewed, and approved CSV deliverables Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Validation Summary Report for SCADA systems.
- Responsible for validating the systems for Building Management Systems.
Sr. Executive
Zydus Healthcare Ltd.
12.2017 - 12.2021
- Carrying out the preparation of the IQ, OQ & PQ protocol for Track Wise.
- Responsible for carrying out the investigation activity for deviations & Change Management activity.
- Responsible for carrying out the complaint sate of the systems throughout the life cycle of the systems implementing Change-management process.
- Responsible for implementing CAPA.
- Responsible for carrying out the validation activity for the Quality Management Systems (Track wise).
- Carrying out the preparation activity of URS for Track Wise.
Executive
Lupin Ltd.
01.2013 - 12.2017
- Responsible for carrying out the validation activity for the Elog (Caliber).
- Carrying out the preparation activity of URS for Elog.
- Carrying out the preparation of the IQ, OQ & PQ protocol for Elog.
- Responsible for carrying out the investigation activity for deviations & Change Management activity.
- Responsible for carrying out the complaint sate of the systems throughout the life cycle of the systems implementing Change-management process.
- Deviation findings, investigation and proposing CAPA.
- Carry out investigations for Batch failures and Customer complaints.
- Root cause analysis for each quality or procedure deviations.
- Key team member responsible for internal audit and vendor audit.
- Responsible for client audit and regulatory audit.
- Identify, recommend, and implement effective CAPA.
- Review of CAPA effectiveness every quarter.
- Preparation of process flow and diagrams and Risk assessment documents.
- Preparation, review of standard operating procedures and equipment operating procedures.
- Reviewing of Executed Qualification Reports.
- Audit Exposure (FDA, MHRA, client audits).
- Handling of Change controls and customer complaints.
Technical Supervisor
Zydus Healthcare Ltd.
12.2009 - 12.2010
- Preparation of master BMR.
- Vendor evaluation.
- Involvement in the validation plan in coordination with cross functional teams.
- Involved in the DQ, OQ and PQ.
- Preparation and review of validation plan.
- Preparation and review of validation summary report / qualification summary report.
- Review of executed BMR.
- Review of daily checklist.
- Co-ordination for cleanliness of plant and readiness for audit.
- Deviation findings, investigation and proposing CAPA.
- Carry out investigations for Batch failures and Customer complaints.
- Root cause analysis for each quality or procedure deviations.
- Key team member responsible for internal audit and vendor audit.
- Responsible for client audit and regulatory audit.
Education
B.PHARM -
N.S.C.B.I.P
01.2009
HIGHER SECONDARY - undefined
B.A.K.P
01.2005
MADHYAMIK - undefined
B.A.K.P
01.2003
Skills
- Computer System validation
- EDMS
- ITIL
- SoX Compliance
- GxP Compliance
- Audit Compliance
- GAMP5
- 21 CFR
- GMP
- GDP
- ICH
- SDLC
- MS Azure
- SAP
- AWS
- LIMS
- Caliber QMS
- Elog
- Val Genesis
- Veeva Quality Docs
- DORA
- NIST
- DNB
- DigID
- Good observer
- Proficient in Microsoft Word
- Proficient in Microsoft Excel
- Proficient in PowerPoint
- Ability to communicate
- Ability to collaborate
- Strong presentation skills
DigiD
DNB Controls
NIST
DORA
Languages
Bengali
Advanced (C1)
Hindi
Advanced (C1)
English
Advanced (C1)
Technical Skills And Systems Familiarity
- GAMP5
- 21 CFR
- GMP
- GDP
- ICH
- SDLC
- Sox Compliance
- MS Azure (Infrastructure Qualification PaSS as a service)
- SAP (Landing Zone Qualification on Azure)
- AWS
- LIMS
- Caliber QMS & Elog
- Val Genesis
Disclaimer
To the best of my knowledge and belief this resume correctly describes me, my qualifications and my experiences.
Personal Information
- Father's Name: Tapan Kumar Pal
- Date of Birth: 08/24/87
- Gender: Male
- Nationality: Indian
- Marital Status: Married
- Religion: Hinduism
Certification
Computer System Assurance -enhance to CSV in GxP
Timeline
Senior Consultant
Atos India Pvt Ltd
08.2022 - Current
CDYMAX India Pvt Ltd
01.2022 - 08.2022
Sr. Executive
Zydus Healthcare Ltd.
12.2017 - 12.2021
Executive
Lupin Ltd.
01.2013 - 12.2017
Technical Supervisor
Zydus Healthcare Ltd.
12.2009 - 12.2010
HIGHER SECONDARY - undefined
B.A.K.P
MADHYAMIK - undefined
B.A.K.P
B.PHARM -
N.S.C.B.I.P
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