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Validation Expert
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Validation Maintenance Manager
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Validation Maintenance Manager
20 hours ago
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Senior Human Factors Engineer
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Director of Quality Assurance
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Scientist - Biomarkers
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Post-doctoral Fellow
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Validation Maintenance Manager
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Validation Maintenance Manager
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CQV Engineer
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Senior Data Scientist, E-commerce
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Associate Director/Director, Biomarkers
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Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · GENERAL POSITION SUMMARY · The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell ...
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Immunologist, Full Time
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Sr CSV Engineer
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Scientist - Biomarkers
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Senior AI Scientist
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Validation Expert - Boston, United States - Katalyst HealthCares & Life Sciences
Description
Responsibilities:
Understand and able to review vendor Qualification document package in line with regulatory requirements.
Knowledge of System and Functional Risk assessment / management, defining risk mitigation plan.
Should have good Stakeholder management skills to interact with customer, business, and vendors efficiently.
Subject matter expertise in areas such as Quality Management, Document management, Software Development Life Cycle, Configuration Management and Change Management
Should have good knowledge on Chromeleon LabVantage LIMS and Scitara, should have good understanding of Labvantage Scitara and Chromeleon integration works.
Should be able to author test scripts for Chromeleon and Scitara integration.
Review test scripts for Labvantage LIMS , Chromeleon, SoftMax , Scitara and Labx.
Know how on Equipment and Instrument qualification process and regulations.
Knowledge on Analytical lab instruments like CDS systems, Labx instruments and SoftMax plate reader.
Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity, and Information Security.
Knowledge of various Validation tools and templates used throughout the pharmaceutical industry.
Knowledge and hands on experience conducting periodic review.
Knowledge on new regulations -Enable innovations, Quality by design, CSA.
Technical Writing Experience.
Basics of project leading skills.
Requirements:
Excellent communication (oral and written) and attention to detail.
8 to 10 years Lifesciences, should have analytical instrument and applications exposure.
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11.
Excellent knowledge of computer system validation and GAMP -5 standards.
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