- Legend Biotech USA, Inc. (Raritan, NJ)
- …sub-teams to develop best practices for global initiatives in validation, quality compliance and material/ raw material support. The validation scope comprises a ... Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working on Quality related sub-teams such as change… more
- Cipla (Fall River, MA)
- …Manufacturing and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen ... and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance. Provides data to support management… more
- Cipla (Hauppauge, NY)
- …The incumbent to this role performs and oversees cGMP compliance -based services (commissioning, qualification, validation, consulting, etc.) on equipment and ... the necessary project documentation is complete, accurate and in compliance with cGMP regulations. The job duties for this...but are not limited to the following : Maintain compliance of the validation program to ensure all equipment,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …while ensuring high quality and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend ... indicating data and identifying trends.Provide oversight for trending of quality compliance metrics.Job duties performed routinely require exposure to and handling… more
- Tris Pharma (Monmouth Junction, NJ)
- …supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory agency ... procurement policies and procedures throughout the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement… more
- Merck & Co. (Rahway, NJ)
- …supplies to clinical sites across more than 60+ countries, in compliance with worldwide regulations, company policies and standard operating procedures.The Director, ... of working.Lead a team of technical experts responsible for:CSO Compliance OperationsCSO Integration OperationsGlobal Site SchedulingProcess ownership, KPIs, investigations… more
- Merck & Co. (Rahway, NJ)
- …years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a ... industry experience at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environmentRequired: Experience… more
- Merck & Co. (Rahway, NJ)
- …device-drug integration. Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations. Leverage data analytics and key ... and third-party audits. Conduct structured assessments of key quality and compliance programs to identify gaps against internal standards, regulatory expectations… more
- Cipla (Fall River, MA)
- …standard operating procedures (SOPs) Monitor operational metrics such as efficiency, compliance rates, and resource utilization. Identify areas for improvement in ... Develop and maintain strong professional relationships with suppliers/vendors to ensure compliance with quality standards and timely delivery of goods and services.… more
- Cipla (Fall River, MA)
- …are not limited to the following : Reviewing and confirming the compliance related to raw materials, inprocess and finished product analytical documents. Monitoring ... during routine operation to ensure adherence to procedure. Confirming and ensuring compliance of the protocols and reports of method validations / verifications /… more
