- Insmed Incorporated (San Diego, CA)
- …and operational efficiency of validated systems through participating in release management, change control , periodic reviews, and audit trail reviews. \tOnsite ... Provide operational support in maintaining systems in a validated state including Change Control Assessments, Upgrade and Patch assessments, Release assessments.… more
- Merck & Co. (Rahway, NJ)
- …project, operations, and qualification needs.Execute and develop appropriate system validation, change control , and testing documentation in partnership with ... with flexible operating suites, which can adjust as the clinical pipeline demands change . It is capable of meeting all historic, currently existing, and cutting-edge… more
- Merck & Co. (Durham, NC)
- …on time, every time.-Required Skills: Accountability, Accountability, Adaptability, Change Control Management, Collaborative Communications, Corrective Action ... guidance and review for regulatory filings, process descriptions, investigations, and change requests. Acts as a participant in domestic and international regulatory… more
- Cipla (Fall River, MA)
- …in Inhalation products (MDI) is a plus. Knowledge and handling of deviation, CAPA, change control , FMECA and training. Knowledge and handling of SAP system, ... and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered...master control and Track wise system. During audit part of… more
- Aequor (Fort Worth, TX)
- …and carries out engineering project work with minimal direction. Troubleshoots equipment/process control systems and change control activities. Programs ... PLCs, HMIs, SCADA systems, and inspection systems. Leads small capital projects. Designs and implements modifications to the existing manufacturing equipment that will improve the operational efficiencies. Preferred Qualifications: Experience in a regulated… more
- Cipla (Fall River, MA)
- …of pharmaceutical manufacturing and related documents. Basic understanding of deviation, CAPA, change control , FMECA , OOS,OOT and OOAC. Other Responsibilities ... Basic understanding of mechanical machinery and the operating principles of control systems. Ability to follow both verbal and written instructions. Demonstrated… more
- Eisai, Inc (Exton, PA)
- …providing timely reporting, investigation, and resolution of manufacturing deviations, change control , and corrective/preventive actions. Participate in ... with Upstream/Downstream Operations , Facilities, R&D, Quality Assurance, Quality Control , Validation, and other internal and external functions to support… more
- AUROBINDO (Durham, NC)
- …with IT, QA, and business teams during system implementation and upgrades.Manage change control for validated systems.Support audit readiness and respond to ... team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Automation System (BAS) and Environmental Monitoring System (EMS)Quality Investigation / Change Control System / Documentation System (Track wise, Comet, ... and Environment monitoring team to ensure the facility is in a state of control and update / communicate with all teams with any emergencies and disruptions.Lead the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …budgetary management, resource planning, and fiscal awareness is preferred.Provide technical expertise of Change Control process as well as oversight of the MES ... and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability. #Li-Onsite#Li-DD1The anticipated base… more
