- Legend Biotech USA, Inc. (Raritan, NJ)
- …a Pharmaceutical / GMP facility experience preferred.Computerized maintenance management systems (CMMS)Building Automation System (BAS) and Environmental ... Monitoring System (EMS)Quality Investigation / Change Control System / Documentation System (Track wise, Comet, Veeva Vault, etc )Manufacturing Execution … more
- Merck & Co. (Rahway, NJ)
- …demand pipeline, contribute in Business case creation incorporating input from Business System Owner (BSO) and other stakeholders to ensure alignment with strategic ... Science, Customer Experience Management, Key Performance Indicators (KPI), Management System Development, Pharmaceutical Research, Product Management, Product Roadmap, Product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems .Familiarity with core Quality Management System processes.Strong written ... tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Review change controls, SOPs, and other documentation.Require minimal… more
- Cipla (Fall River, MA)
- …Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & e-Log Book. Knowledge ... with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive, and sense of urgency… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resolving complex scientific / technical problems.Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry ... tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.May support CSV activities as needed.May support equipment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... performance leading to sustained right first-time execution.Knowledge of LMS system .Supports the maintenance and reporting of quality training metrics.Support daily… more
- Syner-G BioPharma Group (Boston, MA)
- …strategic guidance and hands-on expertise to streamline operations, enhance quality systems , and ensure regulatory compliance, empowering our clients to navigate ... plant operations, including labs, manufacturing plants, utilities, equipment, and systems . The ideal candidate will perform routine inspections, maintain documented… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …DMAIC, standard and standardized work, metrics, visual tools, PDCA, Kanban, pull systems , SMED, pareto, FMEA, A3 thinking, time studies, poke yoke, process mapping ... by direct supervision prior to submission.With respect to larger continuous improvement system implementation and improvements, you have the authority to engage with… more
- Merck & Co. (Rahway, NJ)
- …in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering,- or other types of engineering plus ... device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040,… more
- Merck & Co. (Rahway, NJ)
- …well as an established track record in continuous improvement of processes/ systems and talent development across global, culturally diverse teams. -The incumbent ... and ways of working.Lead a team of technical experts responsible for:Managing systems , equipment and processes for label operationsPartnering with IT, suppliers and… more
