- Repligen (Waltham, MA)
- …ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal controls over financial reporting and key digital systems. This role drives ... program, advises on risk mitigation strategies, and partners closely with Internal Audit, IT, Financial Reporting, and external auditors to strengthen Repligen's… more
- Merck & Co. (Rahway, NJ)
- …for leading and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes ... execution of device development strategies and drive continuous improvement in design control and risk management processes. This individual will be expected to… more
- Merck & Co. (Durham, NC)
- Job DescriptionOur Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range ... and process deviations and complex material-related)Authoring deviation investigationsCollaborate with internal /external partners, eg Our Company sites, Procurement, Raw Material… more
- Cipla (Hauppauge, NY)
- … Internal External Business stakeholders - Manufacturing, Packaging, Quality Control , Quality Assurance, R&D, Engineering, Finance, HR etc., IT business partners ... applications needed to have best in class engagement with internal employees, Vendors/Partners, Customers etc. Evaluate new technologies, develop innovative… more
- AUROBINDO (Durham, NC)
- …team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, ... world to live in.Job OverviewThe QC Supervisor focused on the Quality Control Laboratory, offering project and task management along with technical leadership. The… more
- Cipla (Fall River, MA)
- …management evaluation of performance trends. Owns quality records (change control , CAPA's, deviations) and delivers to established timelines. Autonomously leads ... to customers and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate… more
- Cipla (Fall River, MA)
- …to customers and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate ... protocols. Follows strict internal protocols and Standard Operating Procedures (SOPs) as well...a plus. Knowledge and handling of deviation, CAPA, change control , FMECA and training. Knowledge and handling of SAP… more
- Insmed Incorporated (San Diego, CA)
- …efficiency of validated systems through participating in release management, change control , periodic reviews, and audit trail reviews. \tOnsite at San Diego ... on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team members. Author CSV Documents (Validation… more
- Merck & Co. (Rahway, NJ)
- …hazard analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device risk evaluations in compliance with ... cross-functional stakeholders and external suppliers.Support Design Transfer activities to internal and external sites ensuring proper translation and implementation… more
- Insmed Incorporated (NJ)
- …management and remain in a validated state (eg SDLC, IT Change Control ) per associated SOPs, regulatory and security requirements. \tEnsure compliance and ... efficiency of validated systems through participating in release management, change control , periodic reviews, and audit trail reviews.What You'll Do: Develop… more
