- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance of validated...capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development… more
- 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
- Rees Scientific Corporati (Chicago, IL)
- Department: Service Reports To: Regional Service Manager Payroll Type: Salary FLSA Status: Non-Exempt Job Summary:As a System Validation Specialist, you have ... and inspecting monitoring equipment used in healthcare facilities. The System Validation Specialist will maintain a local stock of necessary parts, ensuring… 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)
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Laboratory operations will manage the internal analytical laboratory and ... analytical activities performed at CROs/CDMOs associated with method development, qualification/ validation , transfer and characterization for drug substance, drug product… 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
- 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
- Novo Nordisk Inc. (Durham, NC)
- …support is on site as needed during production activities Coordinate all validation /transfer activities involving MDev support Lead team in successful execution of ... of cGMP's is required Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning, equipment, utility,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all… more
