- Legend Biotech USA, Inc. (Raritan, NJ)
- …facilities within the United States and ensure the sites operate in full compliance with established cGMP requirements. This individual will be a key leader in ... Cell Therapy Quality organization and a champion for quality principles and compliance . The role develops and implements long-term strategies and execution of… 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...Inc. operates as a subsidiary of Cipla (EU) Limited. EEO Statement Cipla is an Equal Opportunity Employer. All… 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
- Cipla (Fall River, MA)
- …member of the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external quality standards at Invagen Pharmaceuticals ... and help mitigate any potential quality risks to product safety and compliance . Familiar with pharmaceuticals operation (preferably MDI) to ensure required … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …shipping validation, and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation, process validation, equipment, ... and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations.Interacts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …successfully implement and maintain tools, standards, policies and procedures in compliance .Handling day-to-day activities for BAS, EMS and other automation and ... facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance .Expertise in GMP compliance knowledge including knowledge of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and retention, and ... Control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures.Support Document Management system users with… more
- Cipla (Hauppauge, NY)
- …calibration, qualification, and validation documentation with accuracy, completeness, and compliance . Regularly reviews, prioritizes, and promptly responds to MFG ... with GAMP 5 systems and 21 CFR Part 11 compliance . Demonstrated ability to interpret and apply pharmaceutical industry...individuals to grow their careers while growing our business. EEO Statement Cipla is an Equal Opportunity Employer. All… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Preventive Actions (CAPA) process and is responsible for ensuring compliance within quality systems processes.Key Responsibilities Provide oversight to the CAPA ... site governance programDrive continuous improvement of quality systems processes.Ensure compliance with current Good Manufacturing Practices (cGMP).Manage multiple and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical problems.Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global ... working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality, or cell therapy. A portion of the 5 years… more
