- Lilly (Durham, NC)
- …as representative of the Quality function. + Approve commissioning qualification / validation documents for computer systems and equipment to ensure compliance ... and packaging areas to monitor GMP programs, and quality systems . + Active on local process teams or indirect...Demonstrate knowledge and understanding of manufacturing process and Quality Systems . + Proficiency with computer systems including… more
- Novo Nordisk (Durham, NC)
- …+ Authority for product release + Quality oversight, review & approval of validation activities associated with projects, new systems , changes to existing ... department. Position will also be responsible for the production activities & validation . Ensuring relevant compliance issues are addressed & handled in close… more
- Revlon (Oxford, NC)
- …+ Assesses the impact of deviations, CAPAs, and associated change request on the validation status of equipment and/or systems . + Assess changes via NPD, change ... follow up on validation plans. + Author Validation Protocols and Reports. (Cleaning, Process, Systems ,...Author Validation Protocols and Reports. (Cleaning, Process, Systems , etc.) + Delivery/Innovation New Product Development (NPD) is… more
- Fujifilm (Holly Springs, NC)
- …System modifications through the change control process + Helps to maintain the validation status of DSM Automation Computerized Systems + Collaborates and ... the Drug Substance Manufacturing (DSM) facility. This includes preparing validation documentation, contributing to the qualification of Drug Substance Manufacturing… more
- Novo Nordisk (Clayton, NC)
- …in cGMP's & validation required + Strong knowledge in Quality Management Systems required + Must be ability to perform tasks independently, accurately & within ... make what matters. The Position Responsible for the production activities & validation . Ensures relevant compliance issues are addressed & handled in close… more
- J&J Family of Companies (Wilson, NC)
- …Description:** Johnson & Johnson is currently seeking a Director Process Engineering, Systems Owner Lead to join our MAKE Asset Management Organization located in ... of support through detailed design, FAT, SAT, and Process Validation of BioNC. + Leading the engineering innovation and...in the turnover of the documentation for the process systems from Eng/Vendor to the J&J document system (review… more
- Fujifilm (Holly Springs, NC)
- …in an FDA regulated facility. * High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems , automation, ... team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy… more
- CBRE (Charlotte, NC)
- …Consultative skills * Ability to prioritize * Interprets and manages risk using systems that demonstrate appropriate control and validation of risk mitigation ... a "license-to-operate" expectation and must be supported by effective management control systems . Procedures need to be established, maintained, and tested to ensure… more
- ThermoFisher Scientific (Greenville, NC)
- …of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data integrity, computer system ... chance to work in a fast-paced environment, ensuring computerized systems operate compliantly and seamlessly to support worldwide pharmaceutical production… more
- US Tech Solutions (Durham, NC)
- …teams for new product introduction, process improvements, continuous improvements, and validation activities. This position works closely with other functions within ... Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report… more
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