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Jay Shukla Email Address


Job Title

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

Last University
Attended Gujarat University
Lives in Reisterstown, Maryland.

Other people working at Pii:

Andrey PavlovSenior Product Specialist Informatics
Bibha DebManager Administration and Operations
Ken LavinQuality Assurance
Mark TrainorSenior Manager Global Supply Chain Planning Business Partner, SAP Enteprise Program
Mark Di IorioQuality Assurance, Director of Process Quality
Theodora MillerSenior Manager Quality Assurance Validation- Cell and Gene Therapy Catalent Pharma Solutions BioPark
Alyson KellyParalegal
N. Stephen********@pharm-int.com
Sheryl BasileExecutive Director Human Resources
Syed AbidiPresident and Chief Executive Officer
Mohammed ShekhaniVice President of Quality
Kurt Nielsen PhdPresident and Chief Executive Officer
Barbara RenzeScientific Writer
Sajid PervezDirector Information Technology, Pharmaceutics International, Inc
K. Brennfleck**********@pharm-int.com
B. Sasaki*******@pharm-int.com
A. Ahmed******@pharm-int.com
Mohammad HamedooniQuality Assurance Inspector
D. Quarles********@pharm-int.com
T. Ng***@pharm-int.com
C. Strauss********@pharm-int.com
S. Beckmann*********@pharm-int.com
A. Borodin********@pharm-int.com
Toni ValeTraining Manager

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