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Patil
Elena Homes, Flat no.-607,
Near Chandrabhaga Corner, Ravet
Pune, India-412101
Mob. no.: +91- 9604249744
E-mail id.: mr.amitpatil1993@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
• 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.
• 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.
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CURRENT ORGANIZATION
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.
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.
• Review of IQ, OQ & and PQ docs. as per 21 CFR part 11, EMEA annex 11 & GAMP 5 compliance.
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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
REFERENCES
The references shall be provided upon request.
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