Sequence | Engineering Consulting Solutions, Life Sciences Industry | Icebreaker

Sequence | Engineering Consulting Solutions, Life Sciences Industry | Icebreaker

Members

Stanley Hryniuk

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Senior Manager, Quality Engineering

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Samir Patel has over 20 years of multifaceted experience in the Life Science industry. Samir has led many consulting projects for life science clients that range from the leading IT, IT QMS, and CSV initiatives for Life Science M&A's, Global IT operations process development, creation of CSA/QMS programs, an IT-based Data Integrity program for lab systems operations to the implementation and validation of numerous lab systems and enterprise applications. Samir has also successfully participated and presented in numerous FDA and International Regulatory Authority audits. Samir is an active member of ISPE, a member of the East Carolina School of Computer Science Corporate Advisory Board, and an active angel/real estate investor. When not working Samir enjoys spending time with his Wife and two young children.

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Senior Process Engineer II Fill and Finish at Takeda

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Experienced professional with over 15 years of Computer Compliance, SQA and Risk Management experience in information technology and computerized systems for the Bio-tech/ Pharma/Med Device Industry (FDA regulated environment) Specialties Include: - IT Compliance (Infrastructure Validation, Enterprise Applications, Software Deployments, etc) - Software Validation for Databases/ Application Servers, Lab Systems, Clinical, Regulatory, etc - CFR 21, Part 11 Remediation (Electronic Signatures, Audit Trails, Security, System Administration, etc) - Authoring and execution of high quality SLDC documentation - Implementing guidelines and policies to comply with applicable regulations Systems Experience Includes: - Empower Chromatography Data System (CDS) - LabVantage/Sapphire LIMS - Nautilus LIMS - Watson LIMS - IDBS E-Workbook - lifeIMAGE (cloud based medical imaging repository) - inviCRO iPACS (Imaging Study Management System) - tranSMART (Data/Analysis Repository) - Donor Management System (DMS) - Engineering Document Management System (EDMS) - SAP - Compliance Wire - Documentum - myCIMS - Sharepoint - Microsoft Office Products: Word, Excel, PowerPoint Volunteer Experience: 2016/2017 ISPE Board of Directors 2015/2016 ISPE Boston Area Product Show Chair 2014 ISPE Boston Area Chapter Volunteer of the Year Award winner in recognition and appreciation of the many contributions and outstanding dedication to the ISPE Boston Area Chapter.

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Experienced Computer System Validation Consultant with expert knowledge of 21 CFR Part 11 compliance and cGMP. Proven leader with a team-oriented focus in guiding successful validation projects focused on Biotechnology and Pharmaceutical manufacturing. Strong interpersonal skills, effective communicator with attention to detail. Well versed in Discoverant process analytics, IQ/OQ/PQ authoring, execution and deviation resolution.