Jay Shukla Email Address

Associate Director, Aseptic Quality Assurance

| Pharmaceutics International, Inc

Twenty-four years of professional Pharmaceutical Industry experience with extensive knowledge in Quality Assurance, Microbiological Quality Control, Sterile Manufacturing Operations, Validation and Compliance for Clinical & Commercial products11+ years in a supervisory role in QA/Microbiology with proven leadership skills to successfully achieve business objectives In-depth technical knowledge of cGMP and Regulatory Compliance for Manufacturing of Sterile Injectable productsExperience interacting with Regulatory agencies (FDA, EMA, MHRA) and Corporate Compliance Auditors utilizing knowledge of aseptic practices and guidelinesComprehensive experience and knowledge of Quality System elements (e.g. Investigations, Root Cause Analysis, CAPA, Complaints, Change Control, SOP’s, Quality Directives, Procedures, Annual Product Quality Review, Microbiological Method development, Training and Compliance)Excellent interpersonal communication and collaborative skills to interact at multiple levels within the organization to manage multiple priorities and deliver excellent resultsThorough understanding of Quality Risk Management principles, Manufacturing Operations and Quality SystemsCORE COMPETENCIESQuality Assurance, Sterile Operations and Compliance Project Management SupportMicrobiology Laboratory- Quality Control Regulatory & Internal AuditsEquipment & Process Validations Investigations & CAPABatch Releases, Master Production Record Team Development & Leadership