- Jabil (Hunt Valley, MD)
- …of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process ... in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ensuring the...teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise… more
- Actalent (Mount Prospect, IL)
- …and packaging of liquid drug products (highly preferred). + Experience with validation of computer systems (preferred). + Experience with serialization ... Job Title: Quality Validation Engineer Job Description We are seeking a...+ Familiarity with pharmaceutical regulatory requirements and standards (eg, FDA , ISO). Additional Skills & Qualifications + Experience with… more
- NTT DATA North America (Highland Heights, KY)
- …Risk Assessments, Validation Summary Reports, SOPs, and technical specifications. Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex ... sequencers, PCR systems). Equipment qualification (DQ, IQ, OQ, PQ) and computerized system validation . Regulatory compliance with FDA 21 CFR Part 11, EU Annex… more
- Haleon (Oak Hill, NY)
- …cleaning validation , Continued Process validation (CPV), Analytical Method validation , and Computer System validation + Collaborates across ... is accountable for oversight, management, and delivery of all Validation Lifecycle components executed across Technical, Engineering, and QC...FDA , Health Canada, or ANVISA) + Maintains site validation master plan (SVMP) + As the site cleaning… more
- NTT DATA North America (Highland Heights, KY)
- …life cycle documentation including URS, FRS, Risk Assessments, Traceability Matrix, SOPs, and Validation Summary Reports. + Ensure compliance with FDA 21 CFR ... qualification (DQ, IQ, OQ, PQ).** + Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP,...discipline required. + Master's degree or professional certifications in Computer System Validation (CSV), GAMP 5, or… more
- Bausch + Lomb (Tampa, FL)
- …the company and is consistent with the company's policies and practices. + Ensure that validation activities meet the requirements of FDA (21 CFR 820 and 21 CFR ... the Job:** This position will perform and/or support the qualification/ validation of the following validation elements: manufacturing/...11), EU Annex 11, ISO13485:2016 and FDA Data Integrity requirements and any other. + Perform… more
- Cognizant (Boston, MA)
- …and business teams. **In this role, you will:** + Develop and implement comprehensive validation and test strategies aligned with FDA , EMA, and GxP standards, ... 2+ years in a management role. + Expertise in Computer System Validation (CSV) and Computer...of ALM Test Management tools. + Deep understanding of FDA , EMA, GxP, and 21 CFR Part 11 requirements;… more
- Astellas Pharma (Sanford, NC)
- **Specialist, QA Validation (Onsite in Sanford, NC)** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, ... This is an **Onsite** role in **Sanford, NC** . The **Specialist, QA Validation ** is responsible for providing quality assurance oversight and support for the… more
- Actalent (Durham, NC)
- …role involves developing and maintaining cGMP operating procedures related to process, computer systems, and equipment validation , ensuring compliance with SOPs, ... + Assist in the development of cGMP operating procedures related to process, computer systems, and equipment validation . + Assure compliance with SOPs upon… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... Validation Specialist is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and Data Integrity Programs (DI),… more