Onsite GMP Compliance Auditor

Raj has more than 20-years of industrial experience. Raj is serving industry as freelance CGMP Consultant, Project Consultant; Remediation Consultant; Auditor and Validation Expert. He has rich domain expertise in pharmaceutical/API/biotech-vaccine/ medical devices/IT/specialty chemicals/cosmetics/ disinfectant/ food organizations. He has been certified in three crucial sections; manufacturing of tablets; manufacturing of oral liquids; and QC testing; by state FDA, India. Also, he has gone through training on by USFDA. He specializes in QA, QC (chemical & microbiology), Regulatory affairs , manufacturing, R & D, Process, Facility layout design and revamping projects, and Administration. His project involvement includes layout designing, project documentation (BOQ-Room Book-URS-SAT-FAT-IQ-OQ-PQ-Change controls-deviations), commissioning-qualification and regulatory approvals. He has audited facilities and faced global audits including WHO Geneva. He acted as consultant USFDA CGMP expert, data Integrity-remediation, batch data reviewer, Testing and manufacturing data reviewer and certification- release of batches (import alert), OOS, market complaint, incident and deviations reviewer. He has prepared-reviewed qualifications documents, process validation, CSV and analytical method validation documents; aseptic practices documents and smoke test and media fill videos. Has supported many clients’ CAPA and deviations. He acted as third party auditor for manufacturing facilities as well as research-testing laboratories. Raj has audited various aseptic & non-aseptic, API, drug, vaccines, clinical labs, and pilot R&D labs, facilities onsite as well as remotely. He has performed gap assessments; risk assessment, audit trail validation; facility plan design review, HVAC-AHU and mfg. operational gaps, handled audits, wrote audit findings and compliance reports. Supported in critical review of CMC information pertaining to manufacture, testing, storage and shipping- regulatory filing data and CMC- eCTD filing documents for Drug Substance as well as Drug Product-Biologicals and chemical. He has guided industries to resolve gaps in facilities design, manufacturing and testing practices, equipment engineering; sterilization qualifications gaps, HVAC qualification gaps, beta lactam contamination. He is an expert in reviewing raw data, batch records, testing records, stability data, impurity profile, computer system data (CDS, nonCDS); reviewing data of complex system like HPLC, GC and forensic data. He has provided expertise for writing effective CAPA towards handling change control, market complaints, laboratory and manufacturing investigations, aseptic processes. He has provided expertise in retrospective complaints investigation, laboratory incidents and real time laboratory incidents-OOS. His work has been honored in the global publication of GSKBIO. He has performed chemical testing, microbiological testing, biological- animal testing and manufacturing operation of tablets-Capsules, syrups-suspensions, creams-ointments, antiseptic liquids, injections and vaccines. He has working experience in non-sterile, sterile, aseptic formulation, bio formulation, lyophilized formulation, hormones and API. He was responsible for releasing batches of solid, liquid dosages, sterile and non-sterile dosages. Besides manufacturing, he has knowledge of quality systems of preclinical & clinical operations. The guidelines acquainted with USFDA, EMEA, HPRA, PIC /S , ICH, WHO-Technical series; India-FDA, ISO13485; ISO15189, ISO 14644-3, ISO22716,ICH-E6, GCP -GLP; OECD, HACCP, 21CFR part 58; part 820; 21CFR part 11, 210,211, 21CFR600 - Biologics; ISPE Baseline Guide, ASTM E2500 ;GAMP 5 Validation Lifecycle. He has good expertise in protocol writing and executing qualification protocols, data reviewing and validation report writing as well as deviation investigation. He has performed qualification of all instruments, equipment, utilities and facilities- HVAC. He has validated highly complex processes, hold period, media-fill, EM, cleaning validation. He has experience of CSV, ERP validation and Track-wise, SAP, LIMS, Vivaldi, Empower software, SPL- eCTD. Also acted as GXP expert for various organizations from aseptic processing, filling-packing projects, formulations projects, active substances, IT, medical devices, cosmetics, and disinfectant projects. He has worked with many international consultants, and he was the prominent consultant from India among world expert for GSKBIO and US firms on various projects. He excelled from junior executive to top management positions and has experience in crucial functions as QA, QC, Regulatory, Process, R&D, Operation and supply, Project, Administration. He has improved many manufacturing processes, process outputs and testing methods and controlled losses. He has resolved many engineering, manufacturing and testing issues besides helping clients for QMS implementation.