Aman Sharma

About Aman Sharma

8+ years of experience in Pharmaceutical & IVD Quality Assurance, I specialize in building and maintaining robust quality systems within highly regulated manufacturing environments. My expertise lies in Commissioning, Qualification & Validation (CQV), Regulatory Compliance, and Quality Management Systems, supporting organizations in achieving operational excellence and global regulatory compliance.Currently contributing to Greenfield manufacturing and validation initiatives at SD Biosensor Inc, I focus on ensuring that processes, equipment, utilities, and computerized systems meet international regulatory expectations and quality standards.Extensive Experience in different Formulation : My professional journey spans diverse pharmaceutical and diagnostics sectors including Small Volume Parenterals, Pre-Filled Syringes, Dry Powder & Lyophilized Injections, Oncology Products, Oral Solid Dosage (OSD), and In-Vitro Diagnostics (IVD).Core Expertise:• Commissioning, Qualification & Validation (Equipment, Process, Cleaning, HVAC, Utilities)• Media Fill Studies & Temperature Mapping• Computer System Validation (CSV)• Quality Management Systems (QMS) Implementation• Annual Product Quality Review (APQR)• GMP Compliance & Inspection Readiness• Risk Management, Deviation & CAPA ManagementRegulatory Exposure:Hands-on experience with global regulatory standards and inspections including:EU-GMP | WHO-GMP | ISO 13485:2016 | ISO 9001:2015 | MDSAP | CDSCO | ANVISA | TGA | MOH | TMDA | NAFDACAudit & Compliance Experience:Experienced in Contract Manufacturing Audits for leading global pharmaceutical companies including:(Cipla, Sun Pharma, Lupin, Abbott, Dr. Reddy\'s, Piramal, Torrent etc.)Technical Systems Expertise:SAP | Caliber eDMS | LIMS | Ample Logic |Caliber eQMS | Nichelon 5-TMS | SPINEI am passionate about driving quality culture, strengthening compliance frameworks, and supporting the delivery of safe, reliable healthcare products through robust validation and quality systems.

Experience

1. Senior Executive Quality Assurance

   SD BIOSENSOR INC

   Aug 2024 — Present · Gurugram, IN

   Leading Commissioning, Qualification, and Validation (CQV) activities and ensure compliance with global regulatory and quality standards.Responsible for overseeing Greenfield project commissioning, equipment qualification, process validation, and new product integration across India manufacturing units, ensuring alignment with cGMP requirements and regulatory expectations.Key Responsibilities• Lead Commissioning, Qualification & Validation (CQV) activities for manufacturing equipment, utilities, and facility systems across Greenfield operations.• Execute and oversee IQ, OQ, PQ lifecycle management ensuring compliance with GMP and global regulatory standards.• Manage Process Validation, Cleaning Validation, HVAC & Utility Qualification to support manufacturing readiness and product quality.• Support technology transfer and new product integration within pharmaceutical and IVD manufacturing environments.• Collaborate with cross-functional teams (Quality, Engineering, Production, Regulatory Affairs) for validation planning and execution.• Ensure adherence to Quality Management Systems (QMS) and maintain robust validation documentation and compliance frameworks.• Drive continuous improvement initiatives to strengthen validation strategies and operational efficiency.

Education

• K.C.M. SCHOOL Moradabad

  Intermediate

  2013 — 2014

• Dr. A.P.J. Abdul Kalam Technical University

  Bachelor of Pharmacy - BPharm

  2014 — 2018

• K.C.M School Moradabad

  Matriculation

  2011 — 2012