What are the responsibilities and job description for the Quality Assurance Operations Team Lead position at Takeda Pharmaceutical?
Job Description
The Quality Operations Supervisor oversees the daily activities related to the Quality Assurance Operations team, providing quality leadership and focus on product quality and compliance. This role involves supervising a team of Quality Technicians and Quality Analysts, responsible for their continuous development and ensuring they meet performance goals.
Owning Standard Operating Procedures and other Quality Documentation relevant to the Quality department, this supervisor approves procedures and documentation important to all areas of the plant.
This position also entails developing and delivering training materials relevant to Quality operations, approving training materials pertinent to all areas of the plant, and owning investigations and CAPAs relevant to the quality department.
The Quality Operations Supervisor is responsible for approving change controls for compliance to existing requirements, quality approval of labeling artwork and specifications for packaging material using appropriate artwork management software.
This role leads Quality project teams and presents to plant management project plans, progress, and risks, representing the organization to governmental regulatory bodies.
The supervisor is also responsible for approving appropriate documents following cGMP guidelines and suggesting continuous improvement ideas for better processes, reviewing manufacturing processes for cGMP compliance on the floor, and approving raw materials according to standard operating procedures and releasing them for manufacturing use.
Fully participating in internal and external regulatory audits as a SME for Quality operations, this individual presents to auditors and is responsible for AQL and QOTSF programs trending, and escalation for Round Lake site and presenting appropriate data to Quality Council.
