- Actalent (Winston Salem, NC)
- …as assigned by management. Essential Skills + Engineering, quality assurance, quality system , validation , systems engineering. + Understanding of full ... and best practices related to data integrity and computerized system validation . + Foster effective working relationships...practices. + Ensure continued GxP compliance of QC laboratory computer systems and software. + Perform additional… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …+ Assists in the development of cGMP operating procedures that relate to process, computer systems , and equipment validation . + Assures compliance with SOPs ... of our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA /Grifols Quality Systems are adhered to throughout the evaluation, review and… more
- Astellas Pharma (Sanford, NC)
- …coverage and flexibility may be required. **Preferred Qualifications** + Experience with computer verification/ validation . + Experience working in a clinical and ... **Specialist, QA Validation ** Do you want to be part of...responsible for the implementation, execution and assessment of quality systems , procedures, and records to support compliant GMP operations.… more
- Lilly (Durham, NC)
- …maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (eg cGMP's, FDA 21 CFR Part 11) ... member of the site IT organization. The Manufacturing Execution Systems (MES) Systems Engineer is responsible for...a culture of compliance aligned with internal and external computer system quality standards. + Advocate for… more
- Medtronic (Charlotte, NC)
- …resolution are exhausted. This activity may include travel to sites to perform both system repair, validation , and data gathering + Validation of warranty ... and monitor service projects/processes associated with the Robotic Assisted Surgery System . This role will represent service on all appropriate business groups.… more
- Mentor Technical Group (NC)
- …for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory Equipment/ Systems . + Acts as ... comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science...+ Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. +… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …OR 5 years with related technical knowledge including data integrity related to computer systems / data related to manufacturing equipment, QC instruments, and ... submissions. Generally, this requires implementing, as appropriate, and overseeing systems and processes to ensure complete, consistent, enduring, and accessible… more
- United Therapeutics (Research Triangle Park, NC)
- …in a multi-tiered and highly available framework + Execute processes to ensure systems and/or solution achieve and maintain validation and/or qualification in ... regulatory and security policy requirements Minimum Requirements + Associate Degree in computer science, information systems , or related field with 7+ years… more
- GRAIL (Raleigh, NC)
- …and maintenance services to assure equipment reliability. Responsible for maintaining site HVAC systems , Building Automation System (BAS), and other systems ... will work with other maintenance and technical trades, contractors, engineers, metrology, validation , and quality to help keep these systems operational while… more
- Teleflex (Morrisville, NC)
- …controls for Application, ensuring adherence to all relevant IT policies, procedures, and computer systems validation standards Team Leadership * Develop a ... and service providers * Own the process to deploy system changes through sandbox, development, QA and production environments....* Bachelor's degree in a technical field such as Computer Science or Information Systems (a combination… more