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Manufacturing Change Control Specialist

2 mesi fa

Santa Rufina, Lazio, Italia Takeda Pharmaceutical A tempo pieno
About the Role

The Manufacturing Change Control Specialist will oversee the management of GMP documentation and revisions, ensuring thorough and accurate processing. This includes executing training programs to maintain high levels of competency, managing change requests, and conducting risk assessments to mitigate potential issues.

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

Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment.

Why Join Takeda?

Takeda is a Global Top Employer that 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.