Production Documentation Specialist
3 giorni fa
About the Role:
Takeda is seeking a skilled professional to join our team as a Production Documentation Specialist. In this role, you will be responsible for managing production documentation, including the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications. You will also oversee production changes and conduct related risk assessments, ensuring compliance with GDDP and cGMP standards.
Your Key Responsibilities:
- Develop and implement production documentation procedures, ensuring accuracy and compliance with regulatory requirements.
- Collaborate with cross-functional teams to ensure seamless production processes and continuous improvement initiatives.
- Conduct risk assessments and implement corrective actions to ensure quality and compliance.
- Support audits and regulatory inspections, ensuring Takeda's commitment to excellence in production standards.
Requirements:
- Bachelor's degree in a relevant field, such as Chemistry, Pharmaceutical Technologies, or related engineering fields.
- Experience in the pharmaceutical industry, particularly in aseptic production.
- Strong knowledge of GMP regulations, sterile manufacturing, RABS, and Isolators.
- Excellent analytical and problem-solving skills, with the ability to apply scientific methods.
- Strong communication and collaboration skills, with the ability to work effectively in a dynamic team environment.
About Takeda:
Takeda is a patient-focused company that is committed to transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are a global leader in the pharmaceutical industry, with a strong commitment to innovation, excellence, and patient-centered care.
Join Takeda:
At Takeda, we are dedicated to creating a diverse and inclusive workplace that values and empowers our employees to grow and succeed. We offer a competitive compensation package, comprehensive benefits, and opportunities for professional development and growth.
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