Hire Abhishek Mishra, a pharma consultant specializing in FDA Inspections, Medical Devices, 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: Abhishek Mishra is a pharmaceutical validation and compliance professional specializing in computer system validation, qualification documentation, and GxP-regulated systems. His expertise includes GMP compliance, equipment qualification, FDA inspection readiness, quality assurance, change management, deviation investigations, and CAPA. His career includes roles with New England Infotech, National Resilience, Estée Lauder, The RND Group, and Amgen. He brings experience validating laboratory information management systems, clinical data applications, medical device software, and electronic quality management systems. His work covers validation planning, risk assessments, requirements traceability, data integrity controls, and controlled documentation. He helps organizations establish documented validation evidence, manage system changes, and prepare technical records for quality audits and regulatory inspections - Show More
Abhishek supports CAPA activities through experience addressing validation issues, quality records, customer complaints, and product safety risks. His background includes root-cause investigations and corrective action planning across regulated systems and manufacturing environments. He helps teams connect identified problems with documented actions and maintain supporting evidence within established quality procedures.
Abhishek supports change management for computerized systems and pharmaceutical validation activities. His experience includes validation impact assessments, system upgrades, implementation planning, change control documentation, and controlled document revisions. He helps teams assess how proposed changes affect validated systems, define appropriate testing, and coordinate documentation updates before implementation.
Abhishek supports deviation management through experience investigating validation deviations, software anomalies, and testing defects. His work includes root-cause analysis, impact assessments, corrective actions, and resolution documentation. He helps technical and quality teams evaluate issues identified during validation, assess their effect on system performance, and maintain traceable investigation records.
Abhishek supports equipment qualification through preparation, execution, and review of IQ, OQ, and PQ protocols and associated reports. His experience includes autoclave steam sterilization validation and qualification and requalification activities in pharmaceutical manufacturing. He helps teams define testing requirements, document execution results, and resolve issues identified during qualification.
Abhishek supports FDA inspection readiness with a focus on validated systems, data integrity, and technical documentation. His experience includes maintaining inspection-ready records for enterprise applications, laboratory systems, and regulated information systems. He helps teams organize requirements, risk assessments, traceability matrices, validation reports, and controlled documents, drawing on experience supporting internal QA audits and sponsor inspections.
Abhishek supports GMP compliance through computer system validation, data integrity assessments, and controlled documentation practices. His experience includes validating audit trails, access controls, system security, and electronic workflows in regulated environments. He helps teams document system requirements, assess risks, and establish validation evidence supporting GxP operations and electronic record controls.
Abhishek supports quality assurance through review and approval of validation protocols, reports, SOPs, work instructions, and supporting technical records. His background includes document verification, metadata review, version control, and document lifecycle management. He helps quality and system teams maintain complete, traceable documentation and assess validation deliverables against approved requirements and procedures.
