- Cipla (Central Islip, NY)
- …supplier management, and logistics. experience in materials/parts purchase, data analysis, reporting, and providing strategic insights, vendor negotiations, ... continuous improvement. Familiarity with procurement software tools, SAP, Microsoft Suite, GMP, and best documentation practices. Understanding of supply chain and inventory management systems, forecasting, and budgeting. Excellent analytical, problem-solving,… more
- Cipla (Fall River, MA)
- …project milestones and stage gate reviews. Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned ... deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to relevant stakeholders. Maintain effective and pro-active communication and coordination of activities with multi-functional internal and external stakeholders.… more
- Cipla (Hauppauge, NY)
- …in the batch record. Review of engineering records (temperature and humidity data , calibration reports and PMP records). To take daily Quality rounds at ... shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing. Other duties [additional… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …studies conducted at CROs; review protocols, monitor studies, and interpret data .Serve as the primary toxicology subject matter expert for interactions with ... regulatory agencies (FDA, EMA, etc.); support or lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new and ongoing programs, including off-target effects, immunogenicity, insertional mutagenesis, and long-term… more
- Cipla (Fall River, MA)
- …trucks, forklifts, and other devices, as well as computers to maintain data . Follows shipping practices and procedures, and transportation routes, schedules and ... requirements. Receives incoming materials or prepares material for shipment. Un/packs or un/wraps items such as finished products, raw stock, assemblies, parts, building materials, office supplies, equipment, etc. Verifies quantity, weight, and conformance of… more
- Cipla (Hauppauge, NY)
- …projects to establish protocols and test plans. Collect and analyze all data , write final reports and obtain approvals. Review technical documentation such as ... batch records, SOPs, calibration records, preventive maintenance work orders, protocols, reports. Perform gap assessments and remediation as required on legacy validation packages. Interface with the FDA and customers during site audits to respond to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SAP/Ariba or other ERP systems for PO creation, supplier master data , invoice resolution, and spend analysis.Identify and implement opportunities for cost ... savings, process improvements, and risk mitigation.Directly support internal audits, regulatory inspections, and procurement-related documentation.Make recommendations for supplier selection based on quantitative and qualitative analysis.Negotiate contract… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight for trending of quality ... compliance metrics.Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and oversee all engineering management including asset/reliability, data systems/automation and Commissioning/Qualification.Support the development and ... implementation of long-term strategic plans for facility expansion, modernization, validation, and asset management.Direct engineering projects from concept through design and construction, ensuring alignment with budgets, timelines, and business… more
- Insmed Incorporated (NJ)
- …any product alerts in the US.Provide strategic support to the evaluation of data gaps and provide support to the processes related to Investigator Initiated ... Studies.Work collaboratively with key intra- and inter- departmental partners (Field Medical, Medical Operations, Medical Information, Medical Grants, HEOR, Medical Education, Clinical Development, Legal, Regulatory, Commercial, Market Access, etc.Who You… more
