- Amgen (Holly Springs, NC)
- …with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and ... industry standards. + Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment. + Collaborate with cross-functional teams to develop a robust commissioning and… more
- Fujifilm (Holly Springs, NC)
- …applicable * Participates in establishing programs and systems to ensure all GxP requirements associated with the disposition of product batches are phase ... appropriate and complied with * Ensures Disposition process and interdependencies are defined and well understood, and leverages data and technology to drive compliance, efficiency, and monitoring * Ensures integration of Disposition process with other Quality… more
- RELX INC (Raleigh, NC)
- …architecture, and strategy. This role ensures compliance with industry regulations (such as GxP and FDA 21 CFR Part 11), oversees daily operations, drives software ... development best practices, and manages global teams. You will be responsible for planning and executing product delivery while fostering innovation in cloud architecture, security, and software development. Conditions of Employment: + You must be a US citizen… more
- IBM (Durham, NC)
- …relevant technologies and integration patterns. * Familiarity with healthcare-specific GxP compliance and security requirements like HIPPA, GDPR and state-specific ... regulations. * Experience with Agile methodologies. * Ability to convey and convince customers of best practices at various levels within a large organization IBM is committed to creating a diverse environment and is proud to be an equal-opportunity employer.… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …guidance as well as consults with manufacturing and internal regulatory departments on GXP matters. + Uses expertise and sound judgment to make independent decisions ... within defined areas of responsibility. + Plans and analyze work flow, delegate and prioritize, to ensure that assignments and projects are completed in a timely manner and within projected budget. + Participates in regulatory and internal inspections/ audits… more
- Mentor Technical Group (NC)
- …access levels, audit trails, backup, restore, etc. + Knowledge of cGMP, GXP , GAMP, and good documentation practices. + Advanced knowledge of pharmaceutical, ... manufacturing and laboratory systems. + Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry. + Strong written and verbal communication skills. + Excellent interpersonal skills with experience dealing with a… more