The Senior QA Specialist for the Bulk Drug Substance (BDS) facility will be responsible, with management support, for providing oversight of quality activities associated with the manufacturing and disposition of bulk drug substances. They are responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the site to ensure that quality and compliance requirements are followed in line with business needs.
The Senior QA Specialist executes the site QA activities at the company in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.
Purpose: Performs testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing...Apply For This Job
Purpose: The QA Specialist for the Bulk Drug Substance (BDS) Dublin facility at the site will be responsible, with management...Apply For This Job
Purpose: Responsible for planning and conducting quality audits in manufacturing (GMP) within designated Quality Auditing area. Responsibilities: Schedules, prepares, and...Apply For This Job
Purpose: This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company...Apply For This Job
Purpose: To support Product Development and Clinical Supply. To troubleshoot, develop, transfer or validate of analytical test methods as applicable....Apply For This Job
Purpose: Mgr/ Sr Mgr role, key member of the operations management team at Raheen. Provides technical management and support to...Apply For This Job