What are the responsibilities and job description for the Head of Quality Assurance, Operations position at Takeda Pharmaceutical?
Job Title: Quality Operations Supervisor
The Quality Operations Supervisor oversees the day-to-day activities of the Quality Assurance Operations team, providing quality leadership and focus on product quality and compliance. This role involves working with cross-functional teams to ensure adherence to regulations and guidelines.
Key Responsibilities:
- Supervise a team of Quality Technicians and Quality Analysts, ensuring they meet performance objectives and develop professionally.
- Owning Standard Operating Procedures and Quality Documentation, including approving procedures relevant to all areas of the plant.
- Developing and delivering training materials for Quality operations and approving training materials pertinent to all areas of the plant.
- Owning investigations and CAPAs related to quality, and approving change controls for compliance to existing requirements.
- Ensuring Quality Approval of labeling artwork and specifications for packaging material using appropriate software.
- Leading Quality project teams and presenting to plant management project plans, progress, and risks.
- Representing the organization to governmental regulatory bodies and reviewing/approving documents following cGMP guidelines.
- Reviewing manufacturing processes for cGMP compliance and suggesting continuous improvement ideas.
Requirements:
- Bachelor's degree in a science, engineering, or technical field.
- 4 years of related work experience.
- Knowledge of FDA Regulations and Good Manufacturing Practice.
- Experience with visual inspection and AQL processes related to parenteral drugs is preferred.
- Strong Microsoft Office skills (Word, Excel, Project, and PowerPoint).
Working Conditions:
- May work around moving equipment and machinery.
- Must be able to work aligned shift and non-traditional work hours, including weekends and holidays as needed.
- Must be able to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- May work around chemicals requiring respiratory protection.
About Takeda:
Takeda is transforming patient care through novel specialty pharmaceuticals and best-in-class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, committed to delivering Better Health and a Brighter Future to people worldwide.
