- 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
- 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
- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms and systems . + Manage Computer System Validation ( CSV ) activities in alignment with global regulatory ... will make an impact by leading the testing and validation strategy for enterprise-level Document Management Systems ...and validation strategy for enterprise-level Document Management Systems (DMS) within the Life Sciences domain. You will… 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
- Roche (Indianapolis, IN)
- …in the development of new standards and the revision of existing standards related to Computer Systems Validation ( CSV ). + Assemble global feedback on ... systems and services adhere to regulatory standards (eg, CSV , GMP, GCP) and regulatory risks are managed adequately...systems (and some business domains) with regard to Computer Systems Validation and other… more
- Cardinal Health (Augusta, ME)
- …+ Lead the design, development, and deployment of software solutions aligned with FDA computer systems validation ( CSV ) methodologies. + Define technical ... You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT Product team… more
- Lilly (Indianapolis, IN)
- …efforts. + Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems + Validation ( CSV ) of GMP assets including review and ... in a cGMP facility + Prior experience in C&Q, CSQ, and/or CSV + Proficient with computer systems including Microsoft Office, electronic document management … more
- Lilly (Indianapolis, IN)
- …Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation ( CSV ). + Proven ability to ... and release of data including data released from CM, stability, process validation , and reference standard characterization. + Utilizes technical skills to lead or… more
- BeOne Medicines (Pennington, NJ)
- …+ Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). (6+ years) + Strong ... eLogs, etc.. + Technical Transfer experience including equipment qualification, process validation , and computer system validations. + Hands-on experience with… more
- Bristol Myers Squibb (Devens, MA)
- …four (4) years focused on quality assurance, validation , or compliance for computerized systems . + Knowledge of CSV principles, GAMP 5 concepts, FDA 21 CFR ... Cell Therapy Facility (CTF) through managing the computerized system validation ( CSV ) activities / major projects and...& Job Responsibilities:** + Gain a thorough understanding of computer systems deployed at Devens CTF. +… more
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