Expert CSV Consultant Needed

₹750-1250 INR / hour

Closed

Posted 7 days ago

₹750-1250 INR / hour

Overview We are looking for an experienced CSV and regulatory compliance consultant to support a GMP software remediation and validation project for a legacy PLC-based sterilization control system used in a regulated medical device and pharmaceutical environment. Project Background The system is a custom, Do-more Designer H2-DM1E PLC-based sterilization control system with a C-More HMI (Version 4.01), in continuous production use for over 10 years. The system currently has no audit trail, no user access controls, no password management, no electronic signatures, and no SDLC documentation — requiring full 21 CFR Part 11 compliance remediation. Scope of Work Stage 1: Gap Analysis & Risk Assessment including Software FMEA Stage 2: Remediation Planning & SDLC Framework (URS, FRS, Risk Management File, SOPs) Stage 3: Technical Remediation Support & Compliance Oversight Stage 4: IQ/OQ/PQ Validation Execution Stage 5: Closure, Training & SOP Finalization Required Skills & Experience Minimum 5 years hands-on CSV and 21 CFR Part 11 experience Experience with PLC-based systems in GMP environments Strong knowledge of ISPE GAMP 5, FDA QMSR, ISO 13485 Experience writing and executing IQ/OQ/PQ protocols FMEA and risk assessment experience SOP development and training delivery Ability to work independently and deliver on tight timelines

PLC

Risk Assessment

Risk Management

Project ID: 40648176

About the project

4 proposals

Remote project

Active 4 days ago

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4 freelancers are bidding on average ₹981 INR/hour for this job

@cesur135

With over a decade of experience in industrial automation, I bring extensive knowledge to the table for your CSV project. Working on projects such as wastewater treatment plants and water treatment plants has honed my skills in programming, monitoring, and controlling complex systems - skills that will be invaluable for your legacy sterilization control system. I understand the intricacies of PLC-based systems in GMP environments and have a strong grasp on regulatory frameworks including 21 CFR Part 11, ISPE GAMP 5, FDA QMSR, ISO 13485 which will greatly contribute to the remediation and validation project. Moreover, I have proven experience in structuring thorough SOPs, conducting risk assessments (FMEA), and executing robust validation protocols (IQ/OQ/PQ) - crucial elements needed for a successful project like yours. I approach every task with extreme meticulousness, ensuring no stone is left unturned, and nothing compromises your system's compliance standards. Finally, my proficiency in providing structured training and finalizing SOPs will aid your team immensely throughout the project. With me onboard, you can be assured of stringent compliance management adhering to tight schedules. Together, we can ensure that your PLC-based sterilization control system meets the highest standards of quality and safety. Contact me today so we can discuss how I can best contribute to your project!

₹1,000 INR in 40 days

4.9

(6 reviews)

4.2

@kobayasis

Hello, thank you for your detail. I’m interested in supporting this remediation project. I have experience with industrial PLC systems, validation documentation, risk assessment, and regulated system workflows. I understand the challenge here is keeping a 10+ year production system operational while bringing it under a proper 21 CFR Part 11 / GAMP 5 validation framework. I can support the gap assessment, FMEA, URS/FRS, remediation review, IQ/OQ/PQ documentation and execution, and final SOP/handover work. I’d prefer to begin by reviewing the existing PLC/HMI system and documentation, then establish the compliance gaps and remediation priorities before making technical changes. Happy to discuss the current system and validation expectations

₹1,000 INR in 40 days

0.0

(0 reviews)

0.0

@todayintech

? High-Impact Action Plan for "Expert CSV Consultant Needed" I reviewed your requirements and I am ready to deliver outstanding results for you. Experienced Full-Stack Developer skilled in web applications, mobile apps, React, Node.js, and Python. ✅ Deliverables & Execution: 1. Project Setup & Architecture Review (Days 1-2) 2. Core Development & Integration (Days 3-4) 3. Quality Testing & Final Launch (Day 5) Let's connect via chat to discuss your specific goals and get started! Best regards, todayintech

₹1,175 INR in 5 days

0.0

(0 reviews)

0.0

@gopichandp1

I am an experienced CSV/CSA consultant with 7+ years of hands-on experience supporting GxP pharmaceutical and life-sciences environments. I can support this project across gap assessment, risk-based validation, 21 CFR Part 11 remediation, URS/SDLC documentation, IQ/OQ/PQ execution, data integrity, deviations, change control, and validation closure. My experience includes validating manufacturing systems, alarm and exception testing, interface verification, risk assessments, and maintaining inspection-ready validation evidence. I have strong working knowledge of GAMP 5, 21 CFR Part 11, ALCOA+, FDA/EMA expectations, and lifecycle-based validation. For the legacy sterilization control system, I can provide a structured, risk-based remediation approach while working closely with Engineering, Quality, IT, and business stakeholders. I am comfortable working independently and delivering clear, audit-ready documentation within tight timelines. I would be glad to discuss the current system architecture, identified compliance gaps, and the most practical remediation and validation strategy.

₹750 INR in 40 days