- Insmed Incorporated (NJ)
- …Are:You have a Bachelor's degree along with 2+ years of experience ona document control team using a quality management system , with preference to Veeva.You are ... Are you?About the Role:We're looking for a Quality Management System (QMS) Specialist on the Analytical Development team to...based on trend analysis of CAPAs, deviations and change controls .Serve as a key audit contact point by assisting… more
- Merck & Co. (Durham, NC)
- …Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System (DCS), ... Calibration Management Software, Calibration of Equipment, Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Engineering Processes,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in developing, writing and approving technical documents.Experience with Quality systems (Change control , investigations, LIMs, etc.).Extensive technical writing ... the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role… more
- Bayer (IN)
- …Engineer, you will be a key player in implementing and supporting PLC-based control systems and automation solutions within our GxP manufacturing environment. ... vendors for discussions, consultations, and upgrades to optimize our systems ; Project Support: Take the lead on...with relevant technologies in manufacturing; Proficient in manufacturing process control systems , electrical systems , and… more
- Insmed Incorporated (NJ)
- …also: Lead the planning, execution, and documentation of computer system validation (CSV) activities for clinical applications.Collaborate with business owners, ... controls , periodic reviews, and revalidation efforts throughout the system lifecycle.Evaluate and manage third-party vendors and SaaS/cloud-based clinical … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team, responsible for spearheading risk management efforts in ... and post-market surveillance. Key Responsibilities and Activities: The Senior Scientist, Device System - Device Risk Management will be responsible for device risk… more
- Bayer (Whippany, NJ)
- …difference, there’s only one choice. Senior Director, Digital Governance & LMR Lead The Senior Director, Digital Governance & Legal Medical Review (LMR) supports ... primary responsibilities of this role, Senior Director, Digital Governance & LMR Lead , are to: Oversight of External Communication Procedure: Acts as LMR/PRT process… more
- Aptyx (Taunton, MA)
- The Technical Lead is responsible for leading and executing production line activities during an assigned shift to ensure safe, efficient, and compliant ... and adherence to established procedures and performance expectations.ESSENTIAL FUNCTIONS Lead and operate assigned production lines in accordance with Aptyx… more
- Repligen (Waltham, MA)
- …Change Management, System Operations, and IT Governance.Conduct IT application control reviews for key systems (eg, SAP, Tagetik, Workday, ... remediation plans for identified control weaknesses.Serve as SME for system implementations and infrastructure changes to ensure " controls by… more
- Merck & Co. (Rahway, NJ)
- …with regulatory, company, and customer requirements. - Principal Responsibilities Lead /Support continuous improvement initiatives for design control and ... Develop actionable remediation plans and drive their execution through to closure. Lead /contribute to device development, design controls for the assigned… more
- Merck & Co. (Durham, NC)
- …with safety, production, and quality groups to ensure facility operations and systems comply with required standards. Lead / participate in discussions with ... priorities - schedule & cost, installation).Extensive industrial experience involving utility system generation, distribution and controls are needed. Engineer… more
- Cipla (Fall River, MA)
- …to maintain GMP Participate in the internal and external audits to assure system control Review new batch manufacturing records, SOPs, APQR for correctness ... documentation for audit readiness Handle investigations, OOS, OOT, change controls , deviation & CAPA in the block Ensure online...because of limited budget. Overcome by maintaining the centralised control system for minimum stock of spare… more
- Merck & Co. (Rahway, NJ)
- …protocols, Calibration procedures, Training, and SOPs for all GxP automation systems . Lead integration of control systems with MES, Quality, and ... to meet project, operations, and qualification needs.Execute and develop appropriate system validation, change control , and testing documentation in partnership… more
- Merck & Co. (Durham, NC)
- …- schedule & cost, installation). Extensive industrial experience involving utility system generation, distribution and controls are needed. Engineer must ... CMMS experience related to plant maintenance and spare parts procurement systems Project management, including change control and equipment qualification… more
- Cipla (Fall River, MA)
- …preferred. Basic understanding of mechanical machinery and the operating principles of control systems . Ability to follow both verbal and written instructions. ... Operations, and Facilities Operations.Job Description: The Warehouse Coordinatormonitors and controls the production demand for raw material, packing material and… more
- Cipla (Fall River, MA)
- …the equipment and associated controls during the batch run. Act as quality lead for all shop floor questions / concerns. Backup for shop floor QA Associates. ... as temperature and humidity data calibration and PM records, pest control records and contractor related functions. Review and approval of manufacturing/engineering… more
- Twist BioScience (South San Francisco, CA)
- …IT solution requirements and participate in initiatives for ongoing process and systems improvements (eg, ERP, CPQ system enhancements) to increase compliance, ... and procedures, ensuring compliance with all regulatory requirements and SOX controls .Prepare ad-hoc revenue analysis, memos, and respond to both internal and… more
- ValSource, Inc. (Rahway, NJ)
- …with regulatory guidelines, client requirements, and company SOPs. Field Verifications and system walkdowns to confirm systems meet design and client ... currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting… more
- Cipla (Fall River, MA)
- … control , FMECA, OOS, OOT, training and OOAC. Knowledge and handling of SAP system , master control and TrackWwise system . Knowledge of p reparation of ... management evaluation of performance trends. Owns quality records (change control , CAPA's, deviations) and delivers to established timelines. Autonomously leads… more
- Cipla (Fall River, MA)
- …of deviation, CAPA, change control , FMECA and training. Knowledge and handling of SAP system , master control and Track wise system . During audit part of ... leads and manages projects to implement continuous improvement opportunities. Lead and/or support root cause investigations related to performance trends… more
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