- Fujifilm (Holly Springs, NC)
- …and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports * ... Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems * Generates, reviews, and approves QA… more
- Fujifilm (Holly Springs, NC)
- …and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports * ... of experience in GMP Quality Assurance and/or similar role * Experience in Validation , cGMP manufacturing operations and/or Quality oversight, in an FDA … more
- Merck (Wilson, NC)
- …Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . **Summary, Focus and Purpose** The Vaccines Technology Specialist ... be the technical subject matter expert for all aspects of tech transfer, validation , licensure, start up, and ongoing technical support for their area of assignment.… more
- Fujifilm (Holly Springs, NC)
- …the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM ... DSM program * Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems * Provides QA oversight… more
- ITW (Washington, NC)
- …to identify effective solutions for scrap reduction. Compliance/Certification + Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including ... provide for systems review. + Manage Internal Audit Program. New/Change Product/Process Validation + Oversee management of validation activities + Ensure… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …can be audited and reviewed at appropriate intervals + Oversee the selection, validation , and implementation of software used for the generation of cGMP data + ... issued from time to time + Oversee the selection, validation , and implementation of software used for the generation...to, 21 CFR Parts 11, 210, and 211, and FDA data integrity guidance KNOWLEDGE, SKILLS AND ABILITIES: Education:… more
- Medtronic (Charlotte, NC)
- …exhausted. This activity may include travel to sites to perform both system repair, validation , and data gathering + Validation of warranty claim submissions and ... in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA , and internal quality standards. This position is in a fast-paced, ... FDA regulated environment in the Pharmaceutical Industry. This role...+ Supports in the development of methods transfer and validation , troubleshooting, cross validation , IQ/OQ/PQ protocols. +… more
- Reckitt (Wilson, NC)
- …troubleshooting process issues and implementing corrective actions. + Scale-Up & Validation : Support scale-up of new products from R&D to full-scale production, ... including process validation and documentation. + Continuous Improvement: Lead and participate...Compliance & Documentation: Ensure all processes comply with cGMP, FDA , and Reckitt quality standards. Maintain accurate and complete… more
- Lilly (Concord, NC)
- …group during asset delivery, process development, operations readiness, start-up, and validation of the parenteral (PAR) areas which include formulation, aseptic ... Solid understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and/or OSHA. + Excellence in; interpersonal, electronic, written, and… more