Hire Kirtiman Paikray, a pharma consultant specializing in FDA Inspections, Pharmaceutical Manufacturing and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Kirtiman Paikray is a pharmaceutical quality assurance and compliance professional with over 19 years of experience across sterile injectables, APIs, oral solid dosage forms, and regulated business process services. His expertise includes FDA inspection readiness, GMP auditing, supplier qualification, quality management systems, deviation investigations, change management, equipment and facility qualification, and GMP training. His career includes roles with Tech Mahindra supporting the GSK account, Ingenus Pharmaceuticals and Ricon Pharma, Strides Shasun, Biocon, Agila Specialties, and Alkem Laboratories. He brings international experience in quality due diligence, site integration, SOP harmonization, and validation, helping organizations strengthen quality systems, address compliance gaps, and prepare for regulatory inspections. - Show More
Kirtiman supports pharmaceutical change management through impact assessments, compliance risk reviews, and improvements to change control procedures. His experience includes overseeing changes across quality systems and integrated business operations, with attention to documentation, responsibilities, and approval processes. He helps organizations assess proposed changes, coordinate implementation, and track closure through defined governance and performance measures.
Kirtiman supports deviation management through structured investigations, root cause analysis, risk assessment, and corrective action planning. His experience includes leading complex quality investigations and improving deviation workflows through TrackWise and process standardization. He helps teams strengthen investigation documentation, address recurring problems, and improve closure timelines while maintaining oversight of corrective action effectiveness.
Kirtiman supports equipment qualification through the development, execution, and review of lifecycle documentation, including URS, FAT, SAT, DQ, IQ, OQ, and PQ. His experience covers sterilizers, lyophilizers, and manufacturing equipment, alongside associated computerized system controls. He helps teams establish qualification strategies, document testing outcomes, and consolidate results into reports supporting equipment suitability and inspection readiness.
Kirtiman supports facility and utility qualification for pharmaceutical manufacturing sites, including injectable facilities. His experience includes preparing facility qualification reports, Validation Master Plans, and Site Master Files, alongside qualification activities for HVAC, water, and compressed air systems. He helps organizations review qualification evidence, identify gaps, and align facility documentation across new, existing, and integrated sites.
Kirtiman supports FDA inspection preparation through compliance gap assessments, documentation reviews, and evaluation of site quality systems. His experience includes managing international regulatory inspections and preparing validation records, Site Master Files, and supporting quality documentation. He helps organizations identify deficiencies, prioritize corrective actions, and coordinate quality and technical teams to strengthen inspection readiness.
Kirtiman supports internal, corporate, and external GMP audits across pharmaceutical manufacturing sites, laboratories, engineering functions, and computerized systems. His experience includes planning audits, assessing compliance gaps, and preparing reports with findings ranked by risk. He also brings experience in pre-acquisition site assessments, helping organizations evaluate quality risks and establish priorities for remediation and integration.
Kirtiman delivers GMP and quality compliance training for manufacturing, quality assurance, and validation teams. His experience includes international programs covering GxP practices, data integrity, electronic records controls, and quality management systems. He also brings experience in human error reduction workshops and technical mentoring, helping teams improve procedural understanding, investigation practices, and consistent application of quality requirements.
Kirtiman supports the establishment, harmonization, and improvement of pharmaceutical quality management systems across multiple sites. His experience includes digital QMS deployment, SOP development, quality governance, and performance dashboards covering deviations, CAPA, change control, and audit findings. He also helps organizations integrate newly acquired sites and business units through standardized procedures, defined responsibilities, and consistent quality controls.
Kirtiman supports supplier qualification through audit planning, supplier assessments, risk-based approval, and ongoing quality monitoring. His experience includes evaluating GMP compliance, reviewing quality agreements, identifying documentation gaps, and verifying CAPA implementation. He works with suppliers to establish corrective actions and performance measures, helping pharmaceutical organizations strengthen oversight of materials, services, and external partners.
