- 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
- Integra LifeSciences (Princeton, NJ)
- …operations activities. Assess feasibility of and assist in the development and validation of new manufacturing processes for new and existing products. Develop ... and Regulatory Affairs. + Generate technical documents/reports (engineering studies, validation , URS, FAT, production SOPs), compliance documents (ECO, DMR, batch… more
- Spectrum Plastics Master (Wall, NJ)
- …is considered an SME on the utilization of statistics for validation and process capability/performance purposes. * Quality Representative for sustaining Risk ... * Quality Representative for Material Review Board (MRB). * Develop validation and/or verification protocols; execute validations/verifications and report on the… more
- Bausch Health (Bridgewater, NJ)
- …+ Develop, implement, and maintain the change control process in compliance with FDA , EU GMP, and other regulatory guidelines. + Manage change control records within ... Ensure all change control documentation, including justifications, risk assessments, validation requirements, and implementation plans, are completed accurately. +… more
- BeOne Medicines (Hopewell, NJ)
- …and release of material, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne's processes and procedures. ... and external GMP audits where possible. + Lead method transfer and method validation activities, prepare protocols and reports. + Train other junior level analysts… more
- BeOne Medicines (Hopewell, NJ)
- …release of raw materials, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne's processes and procedures. ... and external GMP audits, as needed. + Lead method transfer and method validation activities, prepare protocols and reports. + Train other junior level analysts and… more
- Integra LifeSciences (Plainsboro, NJ)
- …new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & ... new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design &… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and Risk Management + Ensure manufacturing processes meet all regulatory requirements ( FDA , EMA, ICH, GMP, etc.) and industry best practices. + Conduct risk ... + Extensive knowledge of sterile product technologies, including aseptic processing, validation , and cleanroom environments is required. + Expertise in process… more
- Nestle (Bridgewater, NJ)
- …unique opportunity to apply GMP principles to an area as yet unregulated by the FDA . Our unique product provides the opportunity to grow within a cutting edge GMP ... Operation, and Performance Qualification and Requalification Protocols. * Administrate the Validation Management platform and schedule validation events with… more
- Integra LifeSciences (Plainsboro, NJ)
- …design oversight of cost estimating, scheduling, project management, construction administration, validation , with the goal of optimizing Asset Life Cycle Management ... shooting, repairs, and restorations. + Partners with relevant stakeholders to develop Validation Master Plans and validation protocols for new or restored… more