21 CFR Part 11 Compliance & CSV Consultant

₹750-1250 INR / hour

Closed

Posted 7 days ago

₹750-1250 INR / hour

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

Project ID: 40645222

About the project

3 proposals

Remote project

Active 3 days ago

Looking to make some money?

Email address

Benefits of bidding on Freelancer

Set your budget and timeframe

Get paid for your work

Outline your proposal

It's free to sign up and bid on jobs

3 freelancers are bidding on average ₹833 INR/hour for this job

@enricos0

Hi there, Imagine transforming a legacy system into a clean, professional, and user-friendly environment. With over five years of hands-on experience in CSV and 21 CFR Part 11 compliance, I’ve successfully navigated similar projects, ensuring seamless integration and automated processes that meet all regulatory expectations. I see that you require a comprehensive gap analysis and risk assessment, along with a meticulous remediation plan. This is right up my alley, and I fully understand the criticality of addressing the lack of audit trails and user access controls in your PLC-based sterilization control system. I specialize in compliance oversight, SOP development, and training delivery, ensuring that every aspect is covered. My commitment to speedy communication and fast turnaround has resulted in numerous returning clients. I am available for a quick chat! Regards, enricos0

₹750 INR in 7 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