- Catalent (St. Petersburg, FL)
- …and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. ... Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of...and could include all or some aspects of the Quality function.The RoleEnforce Computerized System Validation ( CSV )… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Non-GxP computer systems implementations in partnership with Global DX, and QA - CSV /eCompliance team members to ensure compliant, efficient and timely ... diseases and immune disorders.Summary Manage Global DX Computer System Validation ( CSV ) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and… more
- V2Soft (Tallahassee, FL)
- …Strong understanding of various data formats such as Comma Separate Value ( CSV ), Extensible Markup Lanugage (XML), JavaScript Object Notation (JSON), etc.; This ... team to manage the exchange of information between team members, Architects, QA , Dev/Ops, as well as multiple cross functional teams; Ability to understand… more
- Verista (Durham, NC)
- …to enhance our collective expertise CSV Engineer/Analyst Responsibilities: + Must have CSV QA / quality experience; the ideal candidate will have performed ... test incident reports, etc.) + Summary Reports + Change Controls + Provide CSV QA review of system operational and administration procedures to ensure they are… more
- Quality Consulting Group (Cayey, PR)
- …relevant experience + Technical writing knowledge + Organization and Communication skills + Quality / CSV knowledge Quality Consulting Group, LLC is an equal ... QUALITY CONSULTING GROUP, a leader in the pharmaceutical,...USA Responsibilities: + Conducts a compliant validation process for quality information technology systems which requires formal validation documentation… more
- Lilly (Lebanon, IN)
- …audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy ... analysis platforms that will deliver improvements in safety and quality , and process performance. This is a unique opportunity...quality systems + Recognized understanding of regulations governing CSV and data integrity + Speak up with ideas… more
- Verista (Durham, NC)
- …Must be willing to work onsite in either Durham, NC or Elkton, VA + Must have CSV QA experience, with the ideal candidate having performed the final QA ... new skills and learn from our experiences to enhance our collective expertise CSV Engineer/Analyst Responsibilities: Review all IT CSV project and system… more
- Gilead Sciences, Inc. (Frederick, MD)
- …and implements improvements to CQV processes, and related document templates. + Quality Assurance , GMPs, global Health Authority Regulations, and Validation ... mission! We are seeking a highly motivated individual to join us as a Sr Quality Engineer I, reporting to the Associate Director, Quality Engineering in our… more
- Taiho Oncology (Princeton, NJ)
- Sr. Analyst, Quality Assurance Princeton, NJ, USA Req #377 Tuesday, June 18, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... collaborative, and global cross-functional environment. Position Summary: The Senior Analyst, Quality Assurance will be responsible for managing and inputting… more
- Mentor Technical Group (Manati, PR)
- …Engineering, Biology, Pharmacy or Microbiology) + Six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry + Knowledge of ... government regulations and employer Policies. + Reviews and approves the CSV Installation and Operational Qualification Protocol (IOQ) for computerized systems,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …process and build improved efficiency. + Manage the validation system from a Quality Assurance perspective to ensure quality and compliance requirements ... Manager, QA Validation Department: QA Validation Location:...Experience : + A 6-10 years of experience in Quality Assurance or Design Assurance … more
- Lilly (Indianapolis, IN)
- …for people around the world. **Organization Overview:** Product Research and Development (PRD) Quality Assurance ( QA ) is responsible for providing quality ... oversight of all materials used in clinical trials. The PRD QA Engineer is responsible for oversight of Facilities, Utilities, Maintenance, and Equipment (FUME) and… more
- Somatus (Mclean, VA)
- …leader in value-based kidney care, has an immediate opening for a Data Engineer QA to create impact among Somatus' clients and leadership by developing and testing ... data processed into our data warehouse is of high quality and reliability, and that we avoid functional and...working with data housed in file formats including TXT, CSV , JSON, YAML, Parquet, XLSX + Problem-solving aptitude and… more
- Bristol Myers Squibb (Devens, MA)
- …validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects. + Provide CSV input to multi-function ... change controls, deviation ownership of computerized system events, and CSV activities. + Interact with Infinity ( Quality ...environment with at least four (4) years focused on quality assurance , validation, or compliance for computerized… more
- Lilly (Indianapolis, IN)
- …related certifications (eg, CISA, ISO, ITIL, CSQE (ASQ, QAI)) **Other Information:** QA ( Quality Assurance ) Representative must successfully complete the ... and effectively particularly in the pharmaceutical environment. The Global Computer Systems Quality Assurance (CSQA) Artificial Intelligence (AI) Advisor is part… more
- Mentor Technical Group (Caguas, PR)
- …five to (5 to7) seven years of experience in oC&Q Lifecycle, CSV Lifecycle, Equipment/Facilities/Utilities Commissioning and Qualification, QA Systems, for the ... focal point for Facility commissioning & qualification (C&Q) and computer system validation ( CSV ) in support of the delivery of capital projects. + Work on… more
- Bristol Myers Squibb (Manati, PR)
- …lives. Read more: careers.bms.com/working-with-us . Job Description Summary: Supports quality computerized systems for QC/ QA Department including Laboratories ... Practices as applicable. Job Description Details: 1. Support the Quality computerized systems for QC/ QA Department including...7. Responsible for the development, execution, and/or review of CSV documentation for quality systems and the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and Non-GxP computer systems implementations in partnership with Global DX, and QA - CSV /eCompliance team members to ensure compliant, efficient and timely ... and immune disorders. **Summary** Manage Global DX Computer System Validation ( CSV ) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …Catalent employee. **Compliance Manager** is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of… more
- HealthEdge Software Inc (Columbus, OH)
- …and deployment in partnership with the company's global, Product Management, Engineering, Quality Assurance and Interface teams + Provide internal and external ... enablement, enhancement, and management of data integration and data quality in support of the enterprise architecture of the...a variety of data formats like JSON, XML, BSON, CSV , TXT, HL7 and EDI and structure into enterprise-scale… more
