Manufacturing Compliance Manager
2 weeks ago
The Manufacturing Manager, Manufacturing Compliance is a critical member of our team, responsible for leading teams in Deviations investigations, Corrective and Preventive Actions (CAPA) and Change Controls implementation in the Manufacturing function.
Key Responsibilities- Lead teams in Deviations investigations, CAPA and Change Controls implementation
- Participate in or support root cause analyses, CAPAs, & Change Controls implementation in response to investigational findings, improvement initiatives, and/or compliance gaps
- Ensure consistent methodologies are applied to deviations, including compliance with regulatory requirements and Takeda policies/procedures
- Contribute to the overall site goals and vision as part of the site's Operational Leadership Team
- Bachelor's degree or equivalent experience in Engineering or Science and 7 years of relevant experience in commercial biotechnology or pharmaceutical production
- Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or equivalent and possesses minimally 9 years of relevant experience in the biotechnology or pharmaceutical industry
- Nitec in Biotechnology / Chemical Process Technology or equivalent with minimally 12 years of relevant experience in the biotechnology, pharmaceutical industry
- Prior experience investigating complex deviations is required
- Strong knowledge of formal root cause analysis tools
- Knowledge of cGMP and other regulatory requirements related to manufacturing of biologics
Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. We are transforming patient care through the development of 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, in which 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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Singapur, Singapore Takeda Full timeAbout the Role:The Manufacturing Manager, Manufacturing Compliance is responsible for leading teams in Deviations investigations, Corrective and Preventive Actions (CAPA) and Change Controls implementation in the Manufacturing function.The individual will participate in or support root cause analyses, CAPAs, & Change Controls implementation in response to...
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Singapur, Singapore Takeda Full timeAbout the Role:The Manufacturing Manager, Manufacturing Compliance is responsible for leading teams in Deviations investigations, Corrective and Preventive Actions (CAPA) and Change Controls implementation in the Manufacturing function.The individual will participate in or support root cause analyses, CAPAs, & Change Controls implementation in response to...
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