Production Documentation Management Specialist
3 settimane fa
About the Role:
In the realm of pharmaceutical production, proper documentation management is crucial for maintaining quality and compliance. As a subject-matter expert, you will oversee production changes, conduct risk assessments, and lead projects to enhance production processes and continuous improvement initiatives.
Your Key Responsibilities:
- Complete and revise Manufacturing Batch Records and Equipment Specifications, ensuring compliance with GDDP and cGMP standards.
- Implement training on production documentation ownership and collaborate on audits to ensure excellence in production standards.
- Conduct risk assessments and support Change Control processes as a SME for production.
Requirements:
- Relevant degree in Chemistry, Pharmaceutical Technologies, Biology, Biotechnology, or related engineering fields.
- Experience in the pharmaceutical industry, especially in aseptic production.
- Proficiency in GMP regulations, sterile manufacturing, RABS, and Isolators.
About Takeda:
Takeda is a patient-focused company that transforms patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We foster an inclusive, collaborative workplace where our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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