- Formation Bio (New York, NY)
- …Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation ( CSV ).The primary responsibilities ... enabled development organization, there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation ( CSV ) program. This role ... protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in...mitigation strategies CSV Program Oversight: Oversee the CSV team, validation strategy and continuous process… more
- Insmed Incorporated (NJ)
- …you'll have the opportunity to lead the planning, execution, and documentation of computer system validation ( CSV ) activities for clinical applications. ... the Role:We're looking for a Sr Manager, IT Clinical Systems Validation in the IT team to...You'll also:Collaborate with business owners, QA, and CSV teams to ensure validation deliverables meet… more
- Syner-G BioPharma Group (Boston, MA)
- …of automated production systems , with a concentration on computerized equipment and systems validation .Report writing experience for IQ, OQ, PQ, and CSV ... (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems , equipment, and processes for (re)qualification/(re)verification.Support validation … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System Validation ... tasks.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.May support CSV activities as needed.May support… more
- Insmed Incorporated (NJ)
- …LMS applications, compliance business, and IT infrastructurePrevious experience managing computer systems in pharmaceutical environmentsKnowledge of System ... System Owner for the Learning Management System and compliance IT systems , which includes supporting GxP-regulated applications, while also functioning as strategic… more
- Unither Pharmaceuticals (Rochester, NY)
- …Specifications, Functional and Design Specifications. If completed by an external company, the computer systems validation ( CSV ) specialist will be ... Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Specialist would also plan, coordinate and participate in compliant computer system validation ( CSV ) process for systems which require formal ... are hiring a Principal QA Validation Specialist to support validation and qualification of computer systems within IOPS. The Principal QA Validation … more
- Curia (Albany, NY)
- …contributions + Learning platform + And more! Responsibilities Computer Systems Validation + Manage multiple site and global CSV projects at any time + ... CSV Systems Engineer II/III in Albany,...field + Minimum 3 years' experience in quality and computer systems validation and/or information… more
- NTT DATA North America (Pittsburgh, PA)
- …workflows. Experienced in delivering projects in regulated environments, ensuring compliance with FDA Computer Systems Validation ( CSV ) and quality ... accountability and communication structures. Required Qualifications Bachelor's degree in Computer Science, Information Systems , Business, or related field.… more
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