- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Change Control Specialist II as part of the Quality team based in ... Raritan, NJ.Role OverviewThe QA Change Control Specialist II role is an exempt level position with responsibilities for providing quality oversight over the … more
- Cipla (Fall River, MA)
- …requested controlled documentation. Involve in department QMS such as deviation, CAPA, Change Control , APQR preparation. Any other work assigned by Operation ... Job Title : QA Document Control Associate FLSA Classification : Full-Time, Professional Work...Range : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a pharmaceutical environment is responsible for… more
- Merck & Co. (Durham, NC)
- …regulatory filings including technical reports and risk assessmentsAuthor or approve Change Control documentation for complex process, validation, analytical, ... complex subjects to regulatory inspectors-Required Skills: Adaptability, Adaptability, Biodesign, Change Control Management, Chemical Engineering, Collaborative Communications,… more
- Genmab (NJ)
- …a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications Creates quality control ... regulations/guidance's Creates any needed documentation and training for standard processes, change control management and tools Responsible for defining… more
- Insmed Incorporated (NJ)
- …following lifecycle management and remain in a validated state (eg SDLC, IT Change Control ) per associated SOPs, regulatory and security requirements. \tEnsure ... operational efficiency of validated systems through participating in release management, change control , periodic reviews, and audit trail reviews.What You'll… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality Compliance scope includes working on Quality related sub-teams such as change control sub-teams and investigational sub-teams. The material/ raw material ... sub-teams particularly validation, data analytics (including CPV), quality compliance (including change control and investigations), and material/ raw material… more
- Cipla (Central Islip, NY)
- …QA review and approval of the following types of documents: SOP's GMP documents Change control documents Review of system records Perform activities related to ... of the system to Identify, Develop, and Implement Continuous Improvements to the Change Control System, Process, and associated procedures. Evaluate proposed and… more
- Merck & Co. (Durham, NC)
- …SAP transactions, validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an ... reverse osmosis skids, compressed gas systems)Automated Systems (eg Distributed Control System (DCS), Programmable Logic Controllers (PLC))-Clean-In-Place (CIP) Systems-Maintenance… more
- Cipla (Fall River, MA)
- …data to support management evaluation of performance trends. Owns quality records ( change control , CAPA's, deviations) and delivers to established timelines. ... Inhalation products (MDI) is a plus. Knowledge and handling of deviation, CAPA, change control , FMECA, OOS, OOT, training and OOAC. Knowledge and handling of SAP… more
- 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
- 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
- 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
- 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
- Christus Health (Euless, TX)
- …for high-quality decisions. Adhere to organization standards for system configuration and change control . Able to understand complex requirements of end users ... defined project objectives for issue and problem resolution. Follows strict change management processes ensuring proper approval, testing, and validation of system… more
- Christus Health (Coppell, TX)
- …will suffice. Adhere to organization standards for system configuration and change control . Strong technical proficiency in application-specific design and ... defined project objectives for issue and problem resolution. Follows strict change management processes ensuring proper approval, testing, and validation of system… 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
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