Fajar Sidik Email and Phone Number
Professional IT and CSV (Computer System Validation) Consultant in Indonesia, currently as Co-Founder and Director at PT. CSV Farma Indobuana.• 10+ years experience in IT GxP Management & QA.• Knowledgeable in project management.• Expert about Data Integrity and Computer System Validation in Pharma and Medical Device industry.• Knowledgeable in IT infrastructure, software testing, programming, database, server, network and security.• Familiar with IT, GxP and Pharma guideline and regulation.
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Director And ConsultantCfi Gmp ManagementJakarta, Indonesia -
Co-Founder And President DirectorCfi Gmp Management Aug 2021 - PresentIndonesia- Strategic Product and Project Leadership: Lead, define, and align our product, service, and project strategies with industry needs.- Financial Planning and Analysis: Develop budgets, forecasts, and metrics for resource efficiency and accountability.- Marketing and Pricing Strategy: Oversee marketing plans and set competitive, market-relevant pricing for products and services.- Innovation and Customer Solutions: Drive solutions that address customer challenges and keep offerings relevant.-Team and Process Development: Build teams and processes to deliver high-quality products, services, and projects.- Product Evangelism and Public Engagement: Act as the key company evangelist, engaging in conferences and industry discussions to boost product exposure.- Training Development: Design and deliver training on Computerized System Validation, Data Integrity, and IT.- Expert Consulting: Provide expertise in Operations, Compliance, Process, and Computer System Validation.- System Selection and Compliance Support: Guide clients in system/vendor selection, CSV audits, system investigations, and CAPA closure for data integrity compliance.- Technology Infrastructure and Security (CTO Role): Plan and develop a secure technology infrastructure that ensures data integrity and supports sustainable growth. -
Computerized System Validation ConsultantPqe Group Dec 2022 - Jun 2024IndonesiaSupport client for CSV projects also help to improve of the system to comply Data Integrity and regulation. -
Sr. It And Computerized System Validation ConsultantAndamari Pharma Consulting Jan 2020 - Jul 2021Indonesia• Lead computer system validation project all categorised and areas impacted on clients.• Provide expert consultancy in the areas of Operations Management, Compliance, Process, and Computer System Validation.• Support client to select the system/ vendor, preparation csv audit, System Investigation, closing CAPA, Gap assessment & improvement of the system to comply Data Integrity.
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Computerized System Validation ConsultantAntero Engineering Oct 2019 - May 2020Indonesia -
Computerized System Validation ConsultantHalfmann Goetsch Partner Ag - Nnit Group Mar 2019 - Oct 2019Indonesia• Manage projects in GMP, IT infrastructure, Risk & Compliance andProject Quality Management • Provide expert consultancy in the areas of Operations Management, Compliance, Process, and Computer System Validation. -
Sr. It Computerized System Validation EngineerAlcon Aug 2016 - Feb 2019Batam• Lead and support the administrator role for the computerized systems for the site.• Support the site e-compliance initiatives. • Drive and assist on assuring compliance and interpretation of GxP, regulations for computerized systems and Electronic Record / Electronic Signature requirements and Data Integrity requirements. • Lead remediation of computerized system.• Manage Inventory list and Electronic Record Electronic Sign assessment.• Lead validation activities for computerized systems including automation system and Spreadsheet.• Lead and support Failure investigation, root cause analysis and propose appropriate Corrective Action Preventive Action for computerized systems.• Generate project plan and strategy.• Prepare documentation and perform testing of system / software.• Upgrade security of the system (anti virus, firewall, user access, data & file systems).• Manage backup, restore of the system to support DRP and BCP. • Manage incident and problem of the system.• Generate SOP and conduct training to end users. -
Computerized System Validation OfficerSandoz Feb 2013 - Aug 2016Jakarta• Assist business owner to describe the needs into user requirement specification document.• Asses the risk of the system built.• Prepare documentation and perform testing of system / software.• Upgrade security of the system (anti virus, firewall, user access, data & file systems).• Manage backup and restore data system. • Manage incident and problem of the system.• Review performance of the system annually.• Generate SOP and conduct training to end users.• Update Inventory List of computer system. -
It Service DeskSandoz Jan 2012 - Jan 2013Pasar Rebo Jakarta Timur• Troubleshoot first level to end user and Implement ticketing management system.• Troubleshoot and Update IT Infrastructure (Data Center, Switch, Router etc.).• Support global IT project in local site and perform backup rotation.• Support migration from WinXP to Win 7.• Support OS installation and server-client configuration. -
It TechnicianX2 Planet Jan 2011 - Nov 2011Jabodetabek , Indonesia• Installing, configuring and upgrading operating systems and software • Installing, configuring, assembling and repairing computers, network infrastructure and peripherals such as printers, cctv, and related hardware• Troubleshooting and solving hardware and software problem
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Computer Operator Cyber CafeP@Tch Net Sep 2006 - Jun 2007Jabodetabek , Indonesia• Assist customers when they have trouble or questions using computer softwares such asMicrosoft Office, Adobe softwares and all softwares that are being used in the cyber cafe.• Provide services such as encoding, printing, downloading and all other operations provided bythe cafe.• Perform computer maintenance and software installation.• Troubleshoots different kinds of computer programs, hardwares and softwares.• Provide excellent customer care.• Maintain cleanliness and orderliness of the place.• Keep accurate records of logs and inventories of the shop.• Time customers of the number of minutes or hours they will use the computer or internet.
Fajar Sidik Education Details
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Gunadarma University3.14 -
Gunadarma University3.20 -
Sman 99 Jakarta49.15 -
Mtsn 7 Negeri Jakarta
Frequently Asked Questions about Fajar Sidik
What company does Fajar Sidik work for?
Fajar Sidik works for Cfi Gmp Management
What is Fajar Sidik's role at the current company?
Fajar Sidik's current role is Director and Consultant.
What schools did Fajar Sidik attend?
Fajar Sidik attended Gunadarma University, Gunadarma University, Sman 99 Jakarta, Mtsn 7 Negeri Jakarta.
Who are Fajar Sidik's colleagues?
Fajar Sidik's colleagues are Rahmat Hidayat, Lala May.
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Fajar Sidik
Bandung -
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Fajar Sidik
Fresh Graduate Statistics Student At Bandung Islamic University | Data Analyst | Data ScientistBandung
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