Pritpal Singh

About Pritpal Singh

Strategic Technical Operations leader with nearly 20 years in global pharma, biopharma, and medical device industry bridging the gap between science, operations, and business strategy. Specialized in validation strategy, tech transfer, NPI, and leading external manufacturing (CDMO) networks.Leading Validation and Qualification with strategic planning with cross functional teams, manage risk and implement risk mitigation stage gates.Leading Manufacturing Technical Operations with full accountability for product lifecycle management, from technical transfer to commercial supply.Technical Transfer: Orchestrating all technical transfer activities, ensuring seamless scale-up, process validation, and regulatory readiness for new product introductions.Commercial Excellence: Directing commercial manufacturing support and CPV strategies to ensure process robustness, yield optimization, and uninterrupted market supply.List of Expertise: • Validation, Quality Assurance, External Quality Strategy, Quality systems Management and Operational Engineering• Sterile fill finish, Aseptic Fill Finish, Biologics, Cell Therapy, Biosimilars, Pharmaceutical, Medical Device, Biotech Industries• OTC, Solid oral dos, liquids oral dose, vaccines • Process Validation, Expert in stage 2 and Stage 3 of Process validation.• Cleaning Validation, Computer System Validation, Equipment Qualification.• Continuous Process Verification (CPV) and Packaging Performance Monitoring (PPM)• Data Trending, Process Capability and Statistical Process Control including DOE, SPC Graphs.• CAPA, Investigations, Deviation, Investigations, Change Controls, pFMEA/CARA and Gap Traceablity Matrix cGMP,Part • FAT/SAT/ USR Test Strategy, Test Case Design• IQ, OQ, PQ, PPQ, CPV, PKG-PQ/PKG-PPQ/PPM• Equipment/Facility Qualification and Utilities Commissioning• Project Management, Procedures, SOPs, Training Materials• 210 & 211,Part 820, and 21 CFR Part 11• Interface with Senior Leadership Team to provide a unified set of goals and objectives for the Validation team

Experience

1. Associate Director Technical Operation (Technical Center)

   Hikma Pharmaceuticals

   Feb 2024 — Present · US

   Manage New Product Submissions / Launch, Product Lifecycle management.Manage, Process Validation, Cleaning Validation, Equipment Qualification Raw Material Qualification.Manage External Manufacturing Quality Strategy and risk mitigation implementation steps.Manage Technical Projects Transfer and launch of New Products.Manage KPI, multidisciplinary teams, Project allocation, and Streamlining processes across sites.

Education

• Punjabi University

  Master of Science (MS), Chemistry

  2003 — 2005

• Guru Nanak Dev University

  Bachelor of Science (BS), Science Hons

  2000 — 2003

Skills

• Process Improvement
• Quality System
• Quality Systems
• V&V
• Operational Qualification
• Process Qualification
• Installation Testing
• Packaging Performance Monitoring (Ppm)
• Process Performance Qualification (Ppq)
• Quality Assurance
• Packaging Validation
• Spc
• Quality
• Process Validation
• Data Analysis
• Process Capability
• Data Mining
• Validation
• Statistical Process Control
• Design of Experiments
• Root Cause Analysis
• Iq/Oq/Pq
• Continued Process Verification (Cpv)
• Cleaning Validation
• Packaging Line Trails (Plt)
• Regulatory Affairs
• Pharmaceutical Packaging
• Statistical Data Analysis