Vipul Vishwas Kadam

• Designed and developed manufacturing and quality control processes for RT-PCR-based IVD products, aligning with ISO 13485:2016, 21 CFR Part 820, and IVDR requirements.
• Generated comprehensive regulatory documentation including Performance Evaluation Reports and Risk Management Reports as per ISO 14971 standards.
• Executed IQ/OQ/PQ validation activities for instruments and production processes following internal VMP and regulatory guidelines.
• Conducted stability studies according to ICH Q1A (R2) guidelines to support shelf-life claims in submissions.
• Prepared Technology Transfer Protocols and Process Validation Summaries to ensure compliance with EU MDR/IVDR and CDSCO standards.
• Ensured meticulous documentation of lot history, change control, and CAPA to maintain traceability in line with QMS requirements.
• Collaborated with RA, QA, and manufacturing teams to support product lifecycle from R&D to commercial production, ensuring regulatory compliance.
• Maintained critical laboratory equipment and ensured adherence to qualification and preventive maintenance standards.

• Directed Quality Assurance and Regulatory Affairs functions to ensure compliance with CDSCO, FSSAI, FDA 21 CFR Part 210/211, EU GMP, and Schedule M requirements.
• Managed preparation and review of regulatory dossiers, including CTD/eCTD submissions and product master files for domestic and international markets.
• Oversaw product lifecycle documentation, including submission of Product Permission Files under FSSAI regulations and Drug Master Files.
• Facilitated implementation of Product Lifecycle Management system to enhance traceability and document compliance.
• Conducted Regulatory Gap Assessments to align labeling and ingredient claims with updated global regulations.
• Served as liaison with regulatory authorities during inspections and audits, achieving zero critical observations.
• Coordinated timely submission of Annual Product Quality Reviews and Change Control Justifications.
• Provided strategic guidance for new product registrations, including clinical study summaries and health claims justification.

• Led the Quality Assurance and Regulatory Affairs functions for the solid dosage manufacturing facility, ensuring alignment with CDSCO, WHO-GMP, and Schedule M requirements.
• Developed and implemented QA systems, SOPs, and compliance programs aligned with ICH Q8–Q10, ISO 9001:2015, and cGMP guidelines for tablets and capsules.
• Reviewed and approved Master Formula Records (MFRs), Batch Manufacturing Records (BMRs), Process Validation Protocols, and Cleaning Validation Protocols.
• Managed Change Control, Deviation Handling, OOS/OOT Investigations, and CAPA systems, ensuring timely closure and documentation as per QMS.
• Conducted in-process quality checks, line clearance, and batch release activities after ensuring all critical quality attributes (CQAs) were met.
• Handled regulatory submissions and coordinated with external consultants for product dossier preparation (CTD format) for domestic and semi-regulated markets.
• Prepared and maintained key regulatory documents such as:
  Site Master File (SMF)
  Product Dossiers
  Stability Study Reports
  Quality Overall Summary (QOS)
• Ensured regulatory readiness by coordinating internal audits and preparing teams for inspections by CDSCO, FDA, and ISO certifying bodies.
• Conducted Annual Product Quality Reviews (APQRs), trending of quality data, and supported continual improvement of processes and systems.
• Led training programs for cross-functional departments on GMP, GDP, and regulatory requirements.
• Liaised with Regulatory Authorities for license applications, renewals, and compliance submissions.
• Ensured compliance with labelling, pack insert, and regulatory artwork reviews as per applicable drug rules and pharmacopeial standards.

• Supported the QA team in routine tasks such as line clearance, in-process checks, and review of Batch Manufacturing Records (BMRs) under GMP compliance.
• Assisted in the documentation of deviations, CAPA, and change controls, ensuring adherence to the company’s QMS.
• Coordinated with QC and production teams to monitor raw material and packaging material status and sampling procedures.
• Learned and applied Good Documentation Practices (GDP) and data integrity principles across quality documentation.
• Participated in internal audits, GMP training sessions, and gained exposure to Schedule M, WHO-GMP, and 21 CFR Part 211 guidelines.
• Observed and supported the operation of analytical equipment like HPLC, UV-Vis Spectrophotometer, and pH Meter in collaboration with the QC team.
• Developed a foundational understanding of quality assurance systems in pharmaceutical solid oral dosage form manufacturing.

• Led Research & Development activities for Lateral Flow Assays (LFA) and ELISA diagnostic kits in accordance with ISO 13485, IVDR, and CDSCO guidelines for in-vitro diagnostics.
• Developed and optimized LFA test strips for a range of markers including:
  Pregnancy (HCG), Malaria, HIV, HCV, HBsAg, Syphilis, Dengue, S. Typhi, LH, and COVID-19.
• Prepared and validated third-generation ELISA kits for markers such as HIV, HCV, and HBsAg.
• Synthesized and conjugated gold nanoparticles for LFA devices, optimizing conjugate pad performance and signal intensity.
• Handled complete assembly of LFA devices, including:
  NCM coating, gold conjugate pad preparation, sample pad and release pad optimization, and strip cutting & device housing.
• Prepared all required buffers and solutions (blocking, washing, sample diluents) for use in LFA and ELISA protocols.
• Performed ELISA plate coating, stabilization, and control standardization for consistent lot-to-lot performance.
• Drafted and maintained Standard Operating Procedures (SOPs), Manufacturing Batch Records (MBR), and Device History Records (DHR) in compliance with QMS.
• Supported regulatory documentation for product validations, performance studies, and stability reports in line with IVD product registration norms.

Instruments Handled:

• Analytical: Spectrophotometer, Colorimeter, Gel Electrophoresis, pH Meter
• Diagnostic-Specific: Isoflow Reagent Dispenser, LFA strip & sheet cutters, ELISA Plate Reader, ELISA Washer
• Support Equipment: DI Water System, Autoclave, Water Bath, Laminar Air Flow, Industrial Printers, Incubators, Centrifuge

• Contributed to the development and documentation of RT-PCR diagnostic kits for EBV, Chikungunya-Dengue (Multiplex), and JAK2 detection under ISO 13485 and CDSCO guidelines.
• Prepared and aliquoted core reagents: Master Mix, Primer-Probe Mix, Positive & Negative Controls.
• Maintained and authored SOPs, MFRs, BMRs, and BPRs for R&D and pilot-scale batches.
• Supported validation activities, pilot production, and ensured compliance with IVD technical documentation standards.
• Coordinated with QA and RA teams to meet regulatory submission requirements for IVD kits.