Hire Rohan Iyer, a pharma consultant specializing in Anlaytical Testing, Medical Devices, Pharmaceutical Quality and Sterile Manufacturing. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Asia, Australia, Europe, North America, South America
Consultant Type: Independent Consultant
Expertise summary: Rohan Iyer is a GMP and contamination-control focused pharmaceutical consultant supporting sterile and non-sterile facilities with strong expertise in inspection readiness, quality systems, and risk-based compliance. He helps pharma teams design practical SOPs, execute investigations, and build sustainable CAPA programs that reduce repeat observations. Rohan is known for clear gap assessments, hands-on audit preparation, and aligning QA, QC, engineering, and production teams toward consistent GMP execution.
Rohan supports dissolution programs with a compliance-first, performance-driven approach—ensuring dissolution methods are controlled, reproducible, and defensible during audits. He helps set up dissolution execution SOPs, media preparation controls, sampling accuracy checks, and analyst training to reduce variability. When dissolution failures occur, he leads structured investigations across raw material variability, compression/coating changes, equipment qualification, and analyst technique, ensuring root cause and CAPA are meaningful. He also supports dissolution method transfer, stability trending, and scientifically justified specification governance to reduce recurring OOS/OOT and post-approval change risk.
Rohan builds practical GMP systems that reduce repeat deviations and improve audit outcomes. He supports SOP creation and cleanup, investigation quality upgrades, CAPA effectiveness checks, and change control discipline. He helps teams implement stronger documentation habits, training systems, and escalation pathways so issues are handled early and correctly. Rohan also supports validation governance (equipment, cleaning, process) and supplier qualification programs, ensuring risk is managed across the supply chain. His approach is hands-on and operational—bridging QA and production—so compliance becomes a daily habit, not a last-minute scramble before audits.
Rohan supports PMA documentation readiness by improving traceability and consistency across quality and technical evidence. He helps teams align specifications, test methods, validation reports, and stability justifications so reviewers can follow the logic without confusion. His work includes structured document reviews, gap identification, and improving change control and design history alignment where needed. Rohan focuses on making submission support packages audit-friendly—clean version control, clear references, and defensible rationales. This reduces deficiency questions, prevents contradictory statements across documents, and strengthens the submission narrative by connecting controls directly to product risks and intended use.
Rohan specializes in contamination control and smoke studies for aseptic and cleanroom environments. He supports protocol design, worst-case intervention mapping, and execution planning to ensure smoke studies reflect real operations—not ideal conditions. He interprets airflow patterns to identify turbulence, stagnation, reflux, and operator-driven contamination risks, then recommends practical improvements such as equipment repositioning, intervention changes, and SOP refinements. Rohan also supports documentation and re-study planning so corrective actions are verified properly. The goal is simple: defensible smoke study evidence that strengthens aseptic assurance and reduces contamination risk during routine production.
Rohan is a highly accomplished pharmaceutical quality professional with extensive experience in conducting third‑party GMP audits across global manufacturing sites. With a proven track record of assessing compliance against USFDA, EMA, WHO, and PIC/S standards, he brings deep technical understanding of regulatory expectations and risk-based quality systems. His analytical approach and hands-on audit experience enable clients to identify critical gaps, strengthen supplier qualification programs, and maintain inspection readiness. Now offering his expertise as an independent consultant, Rohan partners with pharmaceutical and biotech companies to enhance their quality assurance frameworks and ensure full GMP compliance across the supply chain.
