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: 40642065

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4 freelancers are bidding on average ₹1,390 INR/hour for this job

@haiqaabdulaziz

Hi there, I am a dedicated Customer Support Specialist with excellent communication skills. I can handle customer queries, live chat, and email support efficiently to ensure maximum satisfaction. What I bring to the role: Fast and accurate query resolution Clear communication via email and live chat Data management and record-keeping Patient and professional customer care I am detail-oriented, quick to learn, and ready to start immediately. Best regards, Haiqa

₹1,000 INR in 40 days

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@jyotig9007

Dear Team, I am writing to express my strong interest in leading your end-to-end remediation and validation engagement. With over 15 years of experience in Life Sciences Quality Management Systems (QMS), Computer System Validation (CSV), and Health Authority (FDA/EMA/MHRA) compliance, I bring the exact technical rigor and hands-on execution needed to navigate Stages 1 through 5 of your scope seamless and audit-ready. Having served in senior consulting and quality roles across global pharma organizations (including Accenture and EY), my background directly aligns with your requirements. As an independent consultant, I thrive in fast-paced environments where ownership and delivering high-quality documentation under tight deadlines are non-negotiable. I can take full accountability for writing protocols, facilitating remediation technical support, and training your team for final project sign-off. I would welcome the opportunity to discuss your system architecture, timelines, and how I can help bring your system into full compliance. Thank you for your time and consideration. Regards, Jyoti Gautam Senior Life Sciences Consultant/Advisor

₹2,808 INR in 40 days

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@suryaprakash3002

I can support this project as a hands-on GMP Automation, CSV and 21 CFR Part 11 consultant, with strong practical experience in PLC, HMI/SCADA, pharmaceutical automation, validation, audit trails, data integrity and IQ/OQ documentation. I have worked on PLC-based GMP systems, SCADA/HMI applications, data logging, audit trail implementation, electronic records/signatures, user access controls, validation documentation and 21 CFR Part 11 compliance. For your legacy sterilization control system, I can support the complete remediation lifecycle: • Gap Assessment & Part 11 Compliance Review • Software Risk Assessment / FMEA • URS, FRS and Validation Strategy • GAMP 5-aligned SDLC documentation • User Access, Audit Trail & Data Integrity remediation • IQ/OQ/PQ protocol preparation and execution support • SOP development and training • Validation deviations, CAPA and final report/closure My key advantage is that I understand both sides of the system — the PLC/HMI engineering and the GMP/CSV validation requirements. This allows me to identify practical compliance gaps without losing sight of how the existing production system actually operates. I would be happy to review your existing PLC/HMI architecture, documentation and current gaps and propose a practical remediation and validation approach. Available to start immediately.

₹1,000 INR in 40 days

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@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