- Bristol Myers Squibb (Indianapolis, IN)
- …matters, and defends their work before regulatory agencies and auditors. + Provides CSV expertise and guidance. + Responsible for compliance with local and global ... SOPs during qualification. + Audit and Operational readiness for site. + Ensure complete understanding of corporate policies and procedures related to all aspects of computer system validation and applicable local processes and policies. + Change Management… more
- Lilly (Indianapolis, IN)
- …of policies and procedures, providing oversight for computer systems validation ( CSV ) and platform qualification (including reviewing and approving validation and ... qualification artifacts per procedure), maintaining awareness of corporate and external standards as they relate to validation and qualification, and assurance of inspection readiness within supported areas. Key Objectives/Deliverables: + Establish and… more
- Lilly (Lebanon, IN)
- …operating systems (Windows, etc.), and Cisco Infrastructure. Basic understanding of CSV (Computer system Validation) & SDLC Software Development and Lifecycle (SDLC) ... deliverables. + Experience with disaster recovery, business continuity planning, creating ServiceNow dashboards, and managing tickets within ServiceNow. + Strong understanding\experience supporting business critical applications + Ability to work on multiple… more
- Ascension Health (Indianapolis, IN)
- …Peyton Manning Children's Hospital (PMCH) as a Level One Children's Surgery Verified ( CSV ) and as a Level 1 Pediatric Trauma Center. + Opportunity to teach ... general surgery residents and medical students. + All 3 current surgeons are mid career and would welcome the opportunity to mentor a new grad. Current providers often operate in combo for big cases. + Join a collegial team that works together to prioritize… more
- Cognizant (Indianapolis, IN)
- …in C# and object-oriented programming concepts Author Computer System Validation ( CSV ) documents such as Functional Risk Assessment, Validation Plan, System Test ... Plan, Test Summary Reports (IQ/OQ/UAT), Validation Report, etc. following industry standard GAMS 5 and/or following the client Quality standards. Author and review test scripts (IQ, OQ, PQ) Perform IQ (application and devices), OQ (including the Siemens… more
- Lilly (Indianapolis, IN)
- …supplier selection. + Lead and support delivery strategies, quality assessments, and CSV and C&Q verification plans. + Collaborate with site automation leadership to ... integrate resources into the project team. Assist with site hiring and capability building. + Collaborate with other corporate engineering groups and Lilly IT to develop delivery strategies and execution plans. + Manage project delivery metrics and… more
- Lilly (Indianapolis, IN)
- …support implementation objectives. + Participates in computer system validation ( CSV ), computer software assurance (CSA), and qualification activities according to ... GAMP 5 and 21 CFR Part 11. + Maintains validation status and supports periodic reviews and change management processes. + Ensures data integrity and regulatory compliance throughout the system lifecycle. + Acts as the quality assurance representative or… more
- Novo Nordisk (Bloomington, IN)
- …execute, and approve protocols and reports related to Automation System Validation ( CSV ). This includes deviation reporting during execution + Review and approve ... changes to computerized automation production and laboratory systems through the change control program to assess impact on validated systems + Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to automation… more
- Lilly (Lebanon, IN)
- …(API) sites. The role will assist local teams in the Design, Development, Delivery and CSV of the MES solutions for the new facilities. This role will report to the ... MQ IT Leader for new facilities. What You Should Bring (preferred skills) + Pharmaceutical Manufacturing Regulatory compliance knowledge and experience (cGMP) + Effective people and team leadership skills + Ability to manage and contribute to multiple… more
- CVS Health (Indianapolis, IN)
- …Health Care Delivery department spans CVS MinuteClinic, Oak Street Health, RubiconMD, CSV Healthspire, and other CVS subsidiaries.** **As a Sr. Design Manager for ... a clinical platform team within CVS Health Care Delivery, you will oversee design for an industry-leading clinical operations and population health platform. This platform supports the delivery of high-quality care to diverse populations across our various… more