What are the responsibilities and job description for the Quality Assurance Specialist position at Takeda Pharmaceutical Company Ltd?
Takeda Pharmaceutical is committed to transforming patient care through the development of novel specialty pharmaceuticals and innovative support programs. We are seeking a highly skilled Quality Assurance Specialist to join our team at the Round Lake Innovation Park in Illinois.
About the Role:
- Manage Standard Operating Procedures and other quality system documentation relevant to your area of expertise, ensuring compliance with regulatory agency requirements and internal company standards.
- Develop and deliver training materials related to your field of expertise, promoting knowledge sharing across the organization.
- Participate in the execution and documentation of validation master plans, design qualification, installation qualification, operational qualification, performance qualification, computer system validation, and validation maintenance packages following existing procedures.
Key Responsibilities:
- Review deliverables for compliance to existing requirements, approving validation documentation that establishes novel requirements or assesses risk.
- Lead teams in risk management activities, ensuring effective identification, escalation, and resolution of potential compliance and safety issues.
- Oversee investigations and CAPAs important to responsibilities/expertise, approving investigations and CAPAs relevant to all areas of the plant.
What You Bring to Takeda:
- Bachelor's degree in science, engineering, or other related technical fields.
- 4 years of related experience in quality assurance, regulatory compliance, or a similar field.
