- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas to provide informatics project management, SDLC Quality Model, subject matter, and computer system validation guidance to Global and Regional IT system ... diseases and immune disorders. Summary Deliver the development and implementation of systems and programs to support the business functions of Daiichi Sankyo (DS)… more
- Tris Pharma (Monmouth Junction, NJ)
- …as well as all applicable company compliance guidelines, standards and objectives; Ensures all systems and services are in compliance with GxP , FDA, Data Privacy ... and FDA guidance documents in managing application/system changes in accordance with computer system validation Experience implementing and leading IT change… more
- Merck & Co. (Lower Gwynedd, PA)
- …and molecular biology methods to translate assay development to automated systems including LIMS integrationWorking knowledge of GxP regulations and ... will be expected.-Education: Bachelor Degree in Engineering, Automated Sciences, Computer Science, Biology, Chemistry or equivalent with scientific expertise with… more
- University of Washington (Seattle, WA)
- …Department of Laboratory Medicine and Pathology** has an outstanding opportunity for a ** Computer Systems GxP Validation Specialist** **WORK SCHEDULE** ... manufacture, and distribution. + Maintain an inventory of GxP computer systems , assess validation status, and prioritize actions based on risk.… more
- Bristol Myers Squibb (Indianapolis, IN)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an ... corporate policies and procedures related to all aspects of computer system validation and applicable local processes...and how they relate to existing and new business systems and practices, primarily GxP . + Knowledge… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Specific experience with Veeva Vault products and reporting is a plus + GxP computer systems and validation experience + Knowledge of Quality Systems ... product families, materials, planned and manufactured batches/lots, suppliers/vendors, assets ( computer systems , instruments, equipment), clinical trials, etc.… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**Desired** + Familiarity with regulated systems - general level of understanding of computer systems validation ( GxP ) + Experience as a Enablement ... **_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_** **Essential** + Degree in Computer Science/Business Informatics or other relevant graduate degree required; +… more
- Robert Half Technology (New Haven, CT)
- …and skills in GxP and GxP FDA. * Proficiency in handling Computer Systems and System Validation . * Experience in Compliance Risk management related ... Description We are offering an exciting opportunity for a Computer Systems Validation Specialist in...through risk assessments and gap analyses, ensuring compliance with GxP regulations * Manage the entire System Development Life… more
- PCI Pharma Services (Bedford, NH)
- …+ Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems from supporting GxP manufacturing and QC operations ... of computerized systems . + Author and review validation documents (IQ/OQ/PQ) supporting GxP computerized ...skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Computer Systems Validation Engineer** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...compliance to 21 CFR Part 11, Eudralex Annex 11, GxP and applicable FDA/EMA Guidance; + Collaborate with manufacturing,… more
