USFDA Inspection & CAPA Response Consultant

USFDA Inspection & CAPA Response Consultant Sharvam Compliance | Remote (India) | Commission-only | Independent Consultant USFDA 483 · CAPA · GMP Audit Readiness · Regulatory RemediationAbout Sharvam ComplianceSharvam Compliance builds AI-powered regulatory and revenue intelligence products for manufacturers, exporters, and regulated industries. Our tools are designed for one purpose: to help companies respond faster, recover more, and stay ahead of regulatory exposure — without adding headcount.We are not a traditional consultancy. We build the systems that make great consultants more effective.The situationA USFDA investigator hands a site a Form 483.Within hours, the dynamic changes completely. Leadership escalates. Customers start calling. Export programs come under threat. QA teams scramble for documentation they may not have organised. CAPA discussions begin before anyone has a structured plan — and the 15 business-day response clock is already running.This is not a normal sales cycle. This is response mode.Indian pharmaceutical manufacturers, API companies, CDMOs, and CROs face USFDA inspection pressure every year. Many have experienced 483 observations, Warning Letters, import alerts, or consent decree risk. The cost of a poorly written CAPA response — or a delayed one — can run to crores in lost business, remediation spend, and regulatory exposure.Sharvam has built an inspection response and regulatory intelligence platform specifically for this moment. It rapidly structures observations, maps SOP and documentation gaps, supports root-cause analysis, organises evidence requirements, and accelerates CAPA response workflows across the site's quality and regulatory teams.The product is built and deployed. We need consultants with the credibility, domain authority, and existing relationships to put it in front of the right decision-makers at the right time.Your opening line/"If your site receives a USFDA observation next month, how many days would your team need to produce a defensible CAPA response — and who owns it?/"Most QA Heads and Plant Heads pause at that question. That pause is the beginning of the conversation.What you will sellFDA 483 Response & CAPA Intelligence PlatformGMP Audit Readiness AssessmentSOP Gap Assessment EngineRoot Cause & Evidence BuilderInspection Readiness RetainersQuality Documentation IntelligenceRegulatory Remediation Workflow SupportYou will not need to explain the technology in detail. You will need to open the door, demonstrate the problem using the client's own context, and position Sharvam as the fastest path to a defensible response. Sharvam's delivery team handles the technical execution after you close.Who we are looking forYou have lived this world — not read about it.You have walked inspection floors during live USFDA audits. You have managed 483 observations and sat in the escalation meetings that follow. You have written or overseen CAPA submissions, reviewed them under Warning Letter pressure, or advised QA teams trying to close out regulatory findings before a re-inspection. You understand what it costs — operationally, commercially, and reputationally — when a site's response is inadequate.You have relationships. With QA Heads, Regulatory Affairs Directors, Site Quality Heads, Plant Heads, Manufacturing VPs, or pharma founders and executives. Relationships that you can activate this week — not connections you will need to rebuild from scratch.Ideal backgroundsSite Quality Head · VP Regulatory Affairs · QA Director · GMP Consultant · Pharma Auditor · Regulatory Remediation Specialist · Former CAPA Programme Lead · Quality Systems ConsultantExperience12–20+ years in pharmaceutical QA, regulatory affairs, GMP compliance, or inspection management. Exposure to API manufacturers, CDMOs, CROs, formulation plants, or export-focused pharmaceutical manufacturers strongly preferred. Familiarity with USFDA inspection dynamics, 21 CFR Part 211 requirements, and CAPA adequacy standards is essential.GeographyIndia-based, with access to pharma manufacturing clusters in Hyderabad, Ahmedabad, Pune, Mumbai, Baddi, Vizag, or Bengaluru. Remote engagement is fully supported.The one thing that matters mostWe hire for relationships first. Product knowledge can be taught in a week. Regulatory credibility takes years to build. Networks cannot be manufactured. Tell us five people you could call this week about inspection readiness — that tells us everything we need to know.What is not requiredAn AI or technology background. Software sales experience. Regulatory expertise you don't already have — the platform provides that. Full-time availability. Exclusivity — you may continue your existing practice or advisory work alongside this engagement.Red flags — this role is not right ifYou have no direct pharmaceutical QA or regulatory affairs background. Your experience is purely academic or policy-facing without site-level exposure. You do not have existing relationships with QA, regulatory, or plant leadership at pharma manufacturers. You expect a warm inbound pipeline or a salaried base before demonstrating results.CompensationProject and audit fees pay 25–30% commission, paid within seven days of collection. Emergency remediation engagements pay 20%. Annual retainers pay 15% recurring every month for the life of the contract. Referral-only introductions — where you make the connection but are not involved in the sale — pay 10% of the first-year fee on signing.OTE by Month 3 is ₹4–6L+/month for a consultant with five or more active prospects and one closed engagement. Top performers earn significantly above this. No salary. No exclusivity. No full-time commitment required.Why this worksFDA observations do not trigger procurement cycles — they trigger emergency response. The moment a 483 is issued, the client's priority is singular: produce a credible, defensible CAPA response before the deadline, before the re-inspection, and before the customer relationship is damaged beyond recovery.In that environment, a consultant who calls first with a credible solution wins immediately. There is no committee. There is no six-month evaluation. There is a problem, a deadline, and a decision.You are not selling software. You are helping clients respond faster when the stakes are highest — and earning a substantial commission for doing it.To applyEmail with subject line: USFDA Inspection & CAPA ConsultantIn one or two paragraphs, tell us: the pharma network you can access today, one inspection, CAPA, or regulatory remediation situation you personally handled and what the outcome was, and the types of companies you currently advise or have advised in the last two years.

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