- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system validation or… more
- Pyramid Consulting, Inc (Seattle, WA)
- Immediate need for a talented Validation - Project Manager - Pharma/Biotech (Japanese Preferred). This is a 12+months contract opportunity with long-term ... potential and is located in Seattle, WA(Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 24-31164 Pay Range: $60 - $68/hour. Employee benefits include, but are not limited to, health insurance (medical,… more
- ICONMA (Columbus, OH)
- …background in health care, nutritional products, or similar industries (preferred). Manager will consider a Manufacturing Engineer, Validation Engineer, or ... Responsible for the design, install, commission, validation , and start-up of manufacturing process systems for...but must have required experience in Food or Pharma. Manager Would Like To See Someone With An Aseptic… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the unitized budget against the needs, conducts rigorous negotiation of terms with validation of rates from service providers. Making sure the payment schedules are ... colleagues on the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development… more
- Aequor (Seattle, WA)
- …product or as applicable). End to end management for method transfer & validation activities at contract test sites and internally Create project plans using PM ... Knowledge of analytical method lifecycle, including assay qualification, transfer, validation and maintenance. Experience with implementing release methods in a… more
- Capgemini (Auburn Hills, MI)
- …Events and Safety Case status to the SSTM and the Project (Vehicle Safety Manager ) Approve Safety Validation Reports, gather synthesis and lead Safety Reviews ... Job Description:As a safety manager , you will lead a team of functional...functional safety concept, technical safety concept, item integration, safety validation ).Key Responsibilities Perform Impact Analysis, create subsequent Dependability Plan,… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Essential Functions QA approver for internal computer system validation efforts. Act as liaison to the business for guidance and consultancy on ... system validation . Support computer system audits for review of SDLC...industry or similar.Familiarity with regulations governing software development and validation .Knowledge of Statistical Programming is preferred but not required.Knowledge… more
- Aequor (Thousand Oaks, CA)
- …following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. processes. c) Approve Environmental ... experience with processes involved in manufacturing and distribution, QA, QAL, validation , and process development. Strong communication (both written and oral),… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role Overview ... The Warehouse Operations Manager will work within Technical Operations and be responsible for the ongoing site ramp-up, daily operational management, as well as… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …existing equipment, processes, and instrumentation in accordance with science and risk-based validation (SRV). This role will provide input to project team members ... assistance is available for selected candidate. Relationships Reports to: Senior Manager - Facilities Engineering & Metrology. Number of subordinates with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Eisai, Inc (Exton, PA)
- …to the Pilot Plant and LabsPartner with Site QA in the GMP validation of Lab automation.Document GMP documentation as per Exton SOPs.Partner with Infrastructure ... Services and IT Security for Infrastructure services such as network support, storage, IT security controls on all Lab PCs.Manage vendor relationships, including escalation.Manage specialized device lifecycle, including onboarding/Offboarding, coordinate the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... programming tasks required to support Data Management and Biostatistics, as necessary.Perform validation and QC/QA of CDISC, SDTM domain output in accordance with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...protocol driven activities such as tech transfer and process validation Provides guidance on industry best practices, and quality… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …transfer traceability from Primary Standards to Laboratory Working StandardsSupport validation and production engineers in development of metrological specifications ... for new equipmentDevelop control charts and statistical process controls for calibration standards and resultsAssist in the implementation and maintenance of ISO 17025 (if applicable) Quality Management SystemComplete documentation and reports of all… more
- Aequor (Thousand Oaks, CA)
- …resumes attached of a ideal candidate for this role NOTES FROM HIRING MANAGER : Looking for hands on *STRONG* engineer experience with proper training/ background in ... project cost and schedule impact (risk-based approach). Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and… more
- Merck & Co. (Rahway, NJ)
- …equipment reliability/performance.- Partner with cross-functional teams to implement sterile validation program. Contribute to the planning, design, and execution of ... validation procedures and studies. Actively participate to achieve program...sterile drug product manufactureSAP Training and skills - Project Manager (PM) role, SAP Plant MaintenanceExperience with ProCal as… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and relocation assistance package is available. Relationships Reports to: Manager , Automation Engineering Number of subordinates with direct/indirect referral: none, ... & programming, ideally 'from scratch' Assists with troubleshooting, testing, validation , deployment and on-going maintenance of Automation Systems Normally receives… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …career, of direct reports, and mentors or acts as functional manager of staff resides in other offices as needed.Responsibilities:Protocol Development, Statistical ... development plan, study design, statistical analysis, data display, results validation , interpretation and reporting to accelerate worldwide product submissions and… more
