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CSV Compliance

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8 views3 pages

CSV Compliance

Uploaded by

eyamit.patil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Amit V.

Patil
Flat no. 904, Legacy Fortune Exotica B Wing,
Near Chandrabhaga Corner, Ravet.
Pune, India-412101
Mob. no.: +91-9604249744
E-mail id.: eyamit.patil@gmail.com

Career Overview

Job Title Assistant Manager (Quality-Medical Devices Unit)


Current Organization Sulzer India Pvt. Ltd./Medmix AG Switzerland
Expertise CSV Quality and Compliance, Auditing, Risk Management and Group
Global Exposure  Managed several international CSV projects.
 Travelled to Europe for project training and support

PROFILE SUMMARY

 Amit is a CSV quality and compliance professional having 8 + years. of experience in


the validation of various IT systems complying with 21 CFR part 11, EMEA annex 11,
and GAMP standards.

CURRENT ORGANIZATION

Duration: From 13-Oct-2021 to till date


Role Assistant Manager
Organization Sulzer India Pvt. Ltd.

Functional Skills

 He has very good experience in Project Quality Management for large global projects in the
pharma & and healthcare sectors leading to regulatory and privacy compliances.
 He prepared and reviewed validation deliverables (Change Request, HLRA, Validation Plan,
URS, FRS, Test Plan, Risk Assessment, Traceability Matrix, Defect Log, Test Summary Report,
Validation Report, and change closure) complying with 21 CFR part 11, EU Annex 11, and
GAMP 5 norms.
 Conducted training sessions on various aspects of computer system validation and conducted
trainee assessment. Acting as a Lead auditor for CSV projects, planning audits, executing the
same, and reporting the observation. Ensuring the audit observations compliance.
 Implemented Global Quality Assurance (GQA) approach, policies, and SOPs to local sites.
Conducted internal audits for manufacturing sites.
 Ensuring SOX standards for SOX relevance project, review of testing protocols and results.
Ensuring overall SOX compliance.
 Preparation of SOPs, templates, and work instructions for various CSV processes as per
current regulations and industry standards.
 Stakeholders’ management (Planning meetings, aligning on various topics of CSV, creating
meeting MOM, attending meetings with clients and publishing outcomes.
PREVIOUS ORGANIZATION / EXPERIENCE

Duration: From 19-Nov-2018 to 22-Jan-2021


Role Executive
Organization Sulzer India Pvt. Ltd.

Functional Skills

 Working as a Validation Expert for various CSV projects. End-to-end validation of IT systems as
per current regulations and industry standards.
 Preparation and review of validation deliverables (Change Request, HLRA, Validation Plan, URS,
FRS, Test Plan, Risk Assessment, Traceability Matrix, Defect Log, Test Summary Report,
Validation Report, and change closure) complying with 21 CFR part 11, EU Annex 11, and GAMP
5 norms.
 End-to-end validation of Deep Freezer, e-Sign, SAP, and LIMS as per 21 CFR part 11, EU Annex
11, GAMP 5 norms.
 Preparation of SOPs, templates, and WIs for CSV processes, conducted training on approved
and effective SOPs, templates, and WIs.
 Supporting Change control, deviation, and CAPA activities as a quality representative.
 Review of IT system User access records. Conducting training sessions for quality and project
teams on various aspects of QMS and CSV.

PREVIOUS ORGANIZATION / EXPERIENCE


Duration: From 25-July-2016 to 01-November-2018
Role Senior officer
Organization Wipro India, Pvt. Ltd.
End-to-end validation of various IT systems, maintenance of system
Description validation state as per 21 CFR part 11 and EU annex 11. QMS (SOPs,
templates, WIs, CC, Deviation, CAPA, Audit) implementation and
maintenance.
Client Switzerland-based top Pharma

Functional Skills – CSV Quality & Compliance (Merck)

 Consultation on information/data classification and data privacy registration.


 Preparation of Validation deliverables (HLRA, VP, RA, RTM, Test Plan/Report & VR. Review of
URS, FS, DD, IQ, OQ/PQ specifications, and results.
 Training project team on various aspects of Quality Assurance and CSV quality & and compliance.
 Supporting clients during various regulatory and internal audits. Part of the vendor assessment
team.
 Implementation and maintenance of QMS (risk assessment, change control, deviation, CAPA,
training, audit, etc.).
 Performing periodic reviews for R & D applications. Updating system inventory list.
 Implemented complex applications to global and local sites as per global and local regulations.
 Using automated tools (Veeva QMS, CARA ManGo DMS, JIRA, HP ALM, SP, etc.) for change
control, deviation, CAPA, training, audit, risk assessment, and documentation management.
 Supported client on RFP/RFP review and vendor selection process, attended demo workshops.
perform vendor audits, reviewed audit documents, RFP, RFI, and related documents.
PREVIOUS ORGANIZATION / EXPERIENCE
Duration: From 13 Jan 2015 to 22 June 2016

Organization Syntel India Pvt. Ltd:


Validation of IT system as per 21 CFR part 11, Eu Annex and GAMP 5.
Description Preparation and review of validation deliverables. Managing Training and
audits.
Client Top USA-based Biotech Organization
Functional skills:
 Preparation of Validation deliverables VP, HLRA, TM, Test Plan, Tollgates, Validation
 Preparation of SOPs, WIs, and templates for CSV framework. Regulated systems validation
by agile approach. Implementation of ICE/IGM controls.
 Preparation and review of SOPs, QIs, and templates for quality elements (change control,
deviation, training, risk management, audits, and CAPA.)
 Ensuring 21 CFR part 11, EMEA Annex 11 & GAMP-5 compliance
 Validation of Excel sheets/formulas used for laboratory results calculations.
 Prepared audit SOP, audit plan, checklist, observation report & and compliance report for CSV
internal and external audits. Prepared case study on validation of SAP-based application.
 Change management to SAP & and Non-SAP systems
 Review of project deliverables including VMP, URS, FRS, DS, IQ, OQ, PQ, and VSR.
 Providing support during various cGxP audits like USFDA, WHO, EMEA MHRA & and Indian
FDA. Attending audits at manufacturing sites.
 Ensure the adherence to SOP during new functionality implementation.
 Preparation, review, and approval of SOPs, protocols, and project deliverables.
 Conduct internal audits, circulate the audit observations, and ensure the level of compliance.
 Prepare and submit an external audit compliance report to the Head of Quality for review.
 Prepare review and execute VMP, Quality/Validation Plan, and Report.

PERSONAL DETAILS

Nationality Indian
Language English, Marathi, and Hindi
Marital status Married
Passport no P1853929

EDUCATION
Degree Institution / University Duration
Master of Business Administration Pune University, India 2014-2016
Bachelor of Business Administration Shivaji University Kolhapur. 2012-2014

AWARDS
 Wipro Star Performer Award 2017
 Syntel Associate of the Quarter 2 2015

CERTIFICATION AND TRAINING


Title Institute/Organization
Training on GxP and CSV conducted by Novartis
Completed training at the time of onboarding.
Data Integrity RQA (Research Quality Association)
Data Integrity and Computer System Validation United States Pharmacopeia (USP)

REFERENCES
The references shall be provided upon request.

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