- Sokol Materials & Services (Skillman, NJ)
- …risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + Proficient in ... risk-based validation approaches. + Strong analytical, problem-solving, and communication skills. + Ability to work effectively in team settings and collaborate with… more
- Merck (Rahway, NJ)
- …medical device engineering, particularly in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination ... of product design and development, manufacturing process development, qualification, validation , and design control and risk management techniques to positively… more
- Sokol Materials & Services (Skillman, NJ)
- …focused on utilities and facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, ... ICH guidelines. Knowledge, Skills & Abilities: + Proficient in risk-based validation approaches. + Strong analytical, problem-solving, and communication skills. +… more
- Insight Global (Basking Ridge, NJ)
- …Matrix, and Validation Plans/Reports. Ensure compliance with applicable regulations (eg, FDA 21 CFR Part 11, EU Annex 11, ICH E6(R3)). Collaborate with ... Analyst to enhance and verify the compliance and computer systems validation (CSV) capabilities across systems managed by Global Development Information Management… more
- Lilly (Branchburg, NJ)
- …+ Be responsible for and participate in the installation, configuration, and validation of LIMS applications. Develop and implement project plans, ensuring timely ... of end users, and provide end user training + Perform the pre- validation assessment of all computerized laboratory and/or manufacturing systems, ensuring that all… more
- Nestle (Bridgewater, NJ)
- …the Vowst and Microbiome Sciences team with systems upgrades, computer system validation activities, and system administrative activities. This role is critical to ... in accordance with GxP, HIPAA, EU Annex 11, and FDA 21CFR Part 11 regulations. This role will also...ERP). * Collaborate with Information Technology (IT), Computer System Validation (CSV), and Quality Assurance Validation (QAV)… more
- Teva Pharmaceuticals (Edison, NJ)
- …and Equipment systems, with minimal supervision. + Develop and review Validation / Qualification protocols and reports that challenge the critical parameters ... needed for new products packaging, ensuring alignment with qualification and validation requirements. + Lead the development of User Requirement Specifications (URS)… more
- Sanofi Group (Morristown, NJ)
- …assessment of the measurement properties of a COA instruments; the development and validation of new COA instruments; the development of briefing books or dossiers ... research projects; including gap analyses, implementation, statistical analyses, psychometric validation and dissemination + Manage the qualitative and quantitative… more
- Sokol Materials & Services (Skillman, NJ)
- …integrity principles + Proven attention to details + Comfortable working in an FDA regulated environment. About the Role DUTIES AND RESPONSIBILITIES: * Provide QA ... * Review and approve documents related to Quality, Quality Control, Validation , and Automation. * Review and approve Standard Operating Procedures (SOPs).… more
- Actalent (East Windsor, NJ)
- …Development. + Develop and update analytical test reports/Certificate of Analysis, validation protocols (IQ/OQ/PQ), and stability study reports. + Prepare method ... validation protocol/reports, method transfer protocol/reports, technical documents, including change...relevant databases. + Ensure all QC documentation aligns with FDA , ICH, USP, EP, cGMP, and other regulatory guidelines.… more