- Sumitomo Pharma (Raleigh, NC)
- …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and process development and improvement, implementation of product/process verification, validation activities, and commercialization. Responsibilities for this role also… more
- United Therapeutics (Research Triangle Park, NC)
- …and technical writing skills + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + ... manufacturing operations + A broad knowledge and practical experience of computer , equipment, and application validation (GAMP methodology), cGMPs, and… more
- Oracle (Raleigh, NC)
- …applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, ... device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's Risk-Based… 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
- Astellas Pharma (Sanford, NC)
- …the manufacturing facility. The role will initially support ongoing commissioning and validation activities as the site works towards GMP production readiness and ... includes yet is not limited to; equipment testing, SOP/batch record generation, validation protocol execution support, as well as cross site tech transfer… 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
- United Therapeutics (Morrisville, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... best practices + Review and approve laboratory instrumentation qualification and validation protocols, test method transfer protocols, and other testing protocols,… more
- United Therapeutics (Research Triangle Park, NC)
- …procurement and utilization + Superior database maintenance / development experience + Computer hardware / software validation and change control experience + ... pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …a drug product that is safe for human use. + Executes commissioning and validation activities associated with a new building. This job description is intended to ... + Excellent oral and written communication skills. + Comfortable with using different computer systems to perform data entry. + Willingness to work with and learn… more