Provide leadership of the Crosstex Medical Division Quality Assurance Team; lead quality assurance support to Manufacturing Operations by ensuring timely release of product, resolving quality related issues, improving product quality and investigating customer complaints.
In this role, you would be responsible for successfully managing the activities of the Quality Assurance (QA) Department relating to quality review and on time dispositions for the site, including the evaluation documents for quality processes related to Pharmaceutical Development Services (PDS) and Commercial Operations.
Develop, implement and manage the Construction Inspection and Test Plans (ITP) for all the temporary and pertinent works, in partnership with the responsible design engineers and construction team members.
Establishing and implementing the process controls required to ensure compliance of the process and the product with all pertinent specifications and standards and monitoring compliance with the controls.
Ensure all supplier non-conformances are identified and managed in a timely manner to minimize risk to the company and are documented to maintain a history of supplier performance, with preventive action implemented robustly at the source of the root cause.
Primary liaison for testing resources and support to Business Acceptance Testing (BAT), Performance Testing, Automation Testing and Warranty support.Responsible for Resource forecasting, allocation and utilization.
Takes action to immediately stop any work or activity, related to the which is not being performed or carried out in accordance with the design, Project Agreement (PA) or applicable regulatory requirements.