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Jay Shukla Email Address

abcdef@pharm-int.com

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Job Title

Associate Director, Aseptic Quality Assurance

Company
Pii

| Pharmaceutics International, Inc

Bio

 Twenty-three 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 Systems CORE COMPETENCIES Quality Assurance, Sterile Operations and Compliance Project Management Support Microbiology Laboratory- Quality Control Regulatory & Internal Audits Equipment & Process Validations Investigations & CAPA Batch Releases, Master Production Record Team Development & Leadership

Last University
Attended Gujarat University
Location
Lives in Reisterstown, Maryland.

Other people working at Pii:

Andrey PavlovCDS Informatics Specialist
Bibha DebManager Administration and Engineering and Operations
K. Lavink*****@pharm-int.com
M. Trainorm*****@pharm-int.com
Mark Di IorioQuality Assurance, Director of Process Quality
Theodora MillerSenior Manager Quality Assurance Validation- Cell and Gene Therapy Catalent Pharma Solutions BioPark
Alyson KellyExperienced Legal Professional Seeking Opportunities Involving Contract Drafting, Review, and Negotiation
N. Stephenn*****@pharm-int.com
S. Basiles*****@pharm-int.com
Syed AbidiPresident and Chief Executive Officer
Mohammed S ShekhaniVice President of Quality
Kurt NielsenPresident of Lupin Somerset
Barbara RenzeTechnical Editor, Senior, Military Health, Federal Civilian Division, GDIT Contract
Kdk*****@pharm-int.com
Sajid PervezDirector Information Technology, Pharmaceutics International, Inc
K. Brennfleckk*****@pharm-int.com
B. Sasakib*****@pharm-int.com
A. Ahmeda*****@pharm-int.com
Mohammad HamedooniQuality Assurance Inspector

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