- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. ... or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related to… more
- Catalent (San Diego, CA)
- …Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. ... execute all Performance Management Program (PMP) actions for the site Quality Assurance department. This includes professional development counseling, informal… more
- Novo Nordisk Inc. (Durham, NC)
- …archiving duties & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance . Essential Functions Ensures site compliance ... shop floor. Handles release of raw materials & provides quality oversight, review & approval of validation ...provides quality oversight, review & approval of validation activities associated with minor changes to existing systems.… more
- Novo Nordisk Inc. (Durham, NC)
- …archiving duties and QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance . Essential Functions Ensures site compliance ... or medical device industry General knowledge of Batch Review Processes (BRP), validation processes and Quality Management Systems (QMS) preferred General… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal ... EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical and… more
- Catalent (St. Petersburg, FL)
- …SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The ... Product Manager is responsible for the overall Quality Assurance review and approval of all...in Product Development/ Validation /Engineering project meetings to provide Quality Assurance input with respect to compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team...therapy. A portion of the 9 years must include quality assurance experience. Knowledge of cGMP regulations… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …team to identify roles and responsibilities Work closely with Engineering, Automation, Validation , IT, Manufacturing, Quality Assurance and Quality ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …setting with quality and operations counterparts that include Manufacturing Operations, Quality Assurance , Engineering and Validation , Quality ... handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for...is required. Minimum of 4 years of experience in Quality Assurance related to manufacturing is required… more
- Aequor (Seattle, WA)
- …of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation , etc.). Must complete tasks independently, notify manager of ... great communication - Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …user/desktop support, including Service delivery and Incident response) IT Infrastructure SME for Quality assurance / GMP and Validation : Maintain qualified ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems: Drive and maintain… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- Manager , QA Validation Department: QA ...analysis process and build improved efficiency. + Manage the validation system from a Quality Assurance ... leading integrated research-based pharmaceutical company. POSITION SUMMARY : The Manager , QA Validation is responsible for providing...Experience : + A 6-10 years of experience in Quality Assurance or Design Assurance … more
- Unither Pharmaceuticals (Rochester, NY)
- …Reporting to the Quality Assurance Manager , The Quality Specialist (Development and Validation ) assists and supports the organization with initial ... Quality Specialist - Development & Validation ...compliance, testing and ongoing monitoring of established quality assurance processes. Ensures all standards are… more
- Cook Medical (Pittsburgh, PA)
- …especially the Computer System Applications, Information Technology, and Quality Assurance departments, to establish the philosophy for validation approaches ... integrity, we invite you to apply. The Computer System Validation Manager at Cook MyoSite, Inc. manages...IQs, OQs, PQs, VSs, etc.) as needed.* Work with Quality Assurance to ensure alignment for an… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. ... or More Years First-hand knowledge of GAMP5, GxP and Non-GxP computer system validation and qualification and Computer Software Assurance (CSA), SDLC related to… more
- ThermoFisher Scientific (Middletown, VA)
- …(FMEAs).** **Direct and oversee validation activities for Operations, Engineering, Quality Assurance , and other functional areas.** **Review, revise, and ... requirements.** **Job Description:** **Serve as the primary interface between Operations and Quality Assurance .** **Originate and assist in the preparation and… more
- ThermoFisher Scientific (Middletown, VA)
- …(FMEAs). + Direct and oversee validation activities for Operations, Engineering, Quality Assurance , and other functional areas. + Review, revise, and ... + Serve as the primary interface between Operations and Quality Assurance . + Originate and assist in...audits. + Performs other duties as assigned by Staff Validation Engineer and direct manager . Required Qualifications:… more
- PCI Pharma Services (Bedford, NH)
- … department personnel and cross-functionally with MTS, Manufacturing, Engineering, QC, Quality Assurance , and project management to achieve all project ... future of PCI. **JOB SUMMARY** Reporting to the Senior Manager process Validation , the Process Validation...clients and multiple departments including Operations, MTS, Engineering, Facilities, Quality Control and Quality Assurance .… more
- Truist (Atlanta, GA)
- …States of America) **Please review the following job description:** Truist Senior Audit Manager for Operations and Issue Validation is responsible for providing ... in the delivery of value-added independent and objective risk-based internal audit assurance and advisory services over the technology audit portfolio. The Senior… more
- PCI Pharma Services (Rockford, IL)
- …with Sales, Project Management, Engineering, Maintenance, Production, Technical Services, Quality Assurance , and external customers to determine requirements ... pioneer and shape the future of PCI. **Summary of Objective:** The Validation Engineer is responsible for the qualification/ validation of pharmaceutical… more
