- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner ... areas centered around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …, reliability, and process capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate ... requirements for validationDevelop and implement strategies for equipment IQ/OQ/PQ, process validation , computer system validation and calibrationPerform… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want 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 and data integrity controls. Review CAPA and verification of CAPAs of… more
- Catalent (Philadelphia, PA)
- … Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance. Management ... operating procedures as needed. Provides leadership for Data Integrity and Computer System Validation documentation review and approval for instruments,… more
- Novo Nordisk Inc. (Durham, NC)
- …or medical device industry General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred General ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...preferred Good written & verbal communication skills required Basic computer skills in MS Office, PowerPoint, Word, Excel, etc.… more
- Catalent (St. Petersburg, FL)
- …with other functional areas (eg Product Development, Operations, Customer Service, Validation , Quality Control, etc.) to ensure continued compliance for ... Manager, QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management… more
- Catalent (St. Petersburg, FL)
- …on trend analysis to eliminate future problems. Participates in Product Development/ Validation /Engineering project meetings to provide Quality Assurance input ... Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The… more
- BioAgilytix (Durham, NC)
- …and file permission settings as it pertains to data integrity and computer system validation .Detail oriented and highly organizedExcellent oral and written ... project plans to implement automated solutions to support (GxP) validation and implementation, including protocol/throughput analysis; instrumentation specification; drafting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications solutions to ... Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services… more
- Novo Nordisk Inc. (Durham, NC)
- …validation requirements including a thorough understanding of cleaning, equipment, utility, computer & process validation requirements & concepts is required ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Merck & Co. (Durham, NC)
- …The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the ... Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control… more
- Merck & Co. (Rahway, NJ)
- …conduct with-ICH/GCP and country regulations, policies and procedures, quality standards and-adverse event reporting requirements internally and externally.Acts ... to achieve-Site Ready.Participates & provides inputs on site selection and validation activities.Performs remote and on-site monitoring & oversight activities using… more
- BioAgilytix (Durham, NC)
- …our internal functions to the actions required of an efficient and quality -driven project process. You'll experience a broad range of responsibilities spanning study ... strong working relationship and open communications with all departments, including Quality Control, Quality Assurance and Sample ManagementMaintain accurate… more
- Merck & Co. (Rahway, NJ)
- …as well as the vendor to ensure that the computer system operation and computer system validation is completed and maintained, and that the field devices in ... future changes to the system such as system expansion projects from either a computer system perspective or from a field device perspective as well as also leading… more
- Merck & Co. (Durham, NC)
- …embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for ... system commissioning and qualification documents, change control, automation incidents, Quality Notifications (QNs), and other key automation-related processesProviding direct… more
- Merck & Co. (Durham, NC)
- …embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The Lab Senior ... Responsible for supporting our Manufacturing Division,- Divisional site mission by assuring quality of products and services are of the highest quality ,… more
- Eisai, Inc (Nutley, NJ)
- …compliance, is essential.Experience in managing application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP. Leadership ... leadership to managed services vendors to drive performance improvement, quality , and cost optimization.Drives a culture of continuous improvement that… more
- Aequor (Libertyville, IL)
- …success working in a high-performing, business results-driven environment. Understanding of computer system validation . Familiarity with ERP systems (ie SAP ... in pharma/biotech with experience in Automation, Manufacturing, Supply Chain and Quality System disciplines. The candidate needs to understand shop floor activities,… more
- Merck & Co. (North Wales, PA)
- …ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Merck & Co. (Durham, NC)
- …Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . - Our Company is expanding its global recombinant vaccine ... embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required. Responsible for… more
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