Atul Kadam

Background

About Atul Kadam

Professional with over 14 years of experience in Computerized System Validation (CSV) and Quality Management Systems (QMS) in Life sciences, Biotech and pharmaceutical domain. Problem solver and detail oriented. Fully understand the importance of compliance and data integrity norms. Excellent interpersonal and communication skills. Results driven and focused on achieving success and increased productivity through improvements in operations, quality, and safety.Skills•Lead and Driven projects on enterprise software applications: Trackwise- QMS, Caliber- DMS, Ample logic-LMS, SAP QM module for Vendor/Supplier management, MM module for Handing unit management (HUM), and PP module for new enhancements.•Expertise in the computerized system validation of Commercial off the shelf (COTS), configurable, and Customize software applications in GMP, GCP and GLP environment.•Practical knowledge and implementation of SDLC, Agile, Waterfall, and V model.•Hands-on Digital platform- ValGenesis- Validation life cycle management system (VLMS) for preparation, review, and approval of validation documents•Hands on Quality Management System: Deviation, Quality compliance, Change Control, Risk management, Internal audits, Supplier management, Product complaints, SOP and training management.•Validation: Process validation and Computer system validation.•Qualification: Facility and Equipment Qualification.•Lead Auditor(Self inspection) and Subject matter expert.•Hands on Regulations and Guidelines: Health Canada, 21 CFR, EU, WHO, ISO, ICH, GAMP 5.•Regulatory Agency Audit Faced: Health CANADA, USFDA, MHRA, WHO, EMA, SAHPRA, ANVISA.