- 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
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Catalent (St. Petersburg, FL)
- …to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support ... Document Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure… 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 (Bothell, WA)
- …with 21 CFR Part 11, EU Annex 11 and GAMP standards for DI and validation of automated systems is required. Experience with QA oversight of e-systems for GMP ... initiatives to promote the DI culture within the organization. Ensure the validation , implementation and change management of e-systems used across the site… 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
- 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
- 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
- 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
- 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
- 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
- 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
- Annapurna Labs (US) Inc. (Manchaca, TX)
- …of thousands of businesses in 190 countries around the world.We are seeking a Manager for SI/PI Engineer (Signal Integrity and Power Integrity) who will play a key ... role in the definition, design and validation of AWS next generation machine learning ASICs. As a senior member of our hardware team, you will have a meaningful… 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
- BioAgilytix (Boston, MA)
- …objectives. Playing a pivotal role in our project lifecycle, you'll conduct validation studies on a spectrum of biological samples, ranging from biologics and ... technical reviews of documents prior to review by the project manager (eg, Bioanalytical Project Manager (BPM), Principal Investigator)independently creating… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …shifts to National and Area Accounts leadership Oversee the bi-annual formulary validation process and communication of Market Access formulary wins and losses ... from MAPA leadership to our extended partners General: People manager for the MAPA Execution Team Lead short and...pharmaceutical industry required 3+ years' experience as a people manager in a related Market Access function required Bachelor's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position This position is responsible for providing support to the Senior Manager and Director of Institutional Contracts by leading the team through the ... controls, and Sarbanes-Oxley regulations. Relationships Reports directly to the Senior Manager , Institutional Contracts. Interacts daily with others within the PCOR… more
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