Manufacturing Change Control Specialist
4 settimane fa
About the Role: We are seeking a highly skilled Manufacturing Change Control Specialist to oversee GMP documentation management and revision, ensuring thorough and accurate processing. This role involves executing training programs to maintain high levels of competency, managing change requests, and conducting risk assessments to mitigate potential issues. Additionally, the position supports various projects and plays a key role in preparing for both internal and external audits.
Key Responsibilities:
- Issue and review of GMP Documentation
- Support the maintenance of the GMP documentation archive related to own department, including the responsibility to collect and destroy documents
- Project management and change request opening and management
- Support MES project implementation
- Carrying out activities relating to GMP compliance in the field and operational problem solving
- Identification of improvement opportunities to align GMP compliance in production
- Writing/Executing/reviewing RA
- Performance of staff training regarding specific operating procedures, in compliance with the principles of Lean Manufacturing
- Support in preparing and carrying out internal and external audits
Requirements:
- BS in life sciences or related field
- Manufacturing experience of at least 1 year
- Good science knowledge and main principles of pharmaceutical manufacturing equipment
- Knowledge of cGMP with respect to the production process
- Quality risk management
- GMP documentation experience
- Experience supporting MES implementation
- Organizational and personnel management skills
- Relationship and communication skills
- Good knowledge of the English language
About Takeda: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. We are a patient-focused company that inspires and empowers our employees to grow through life-changing work. 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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