Manufacturing Documentation Compliance Specialist
4 giorni fa
About the Role
Takeda is seeking a highly skilled Manufacturing Documentation Compliance Specialist to join our team in Pisa, Italy.
Key Responsibilities:
- Serve as the primary point of contact for all GMP production documentation activities, ensuring compliance with Good Distribution Practice (GDP) and Current Good Manufacturing Practices (cGMP).
- Develop, revise, and maintain SOPs, MBRs, JA, and other production documents, guaranteeing adherence to regulatory requirements.
- Create and execute training programs for production personnel on documentation processes, focusing on strong training efficacy.
- Collaborate with internal teams, including Engineering, Quality, Supply Chain, and Validations, to ensure seamless execution of manufacturing and visual inspection activities.
- Manage direct reports involved in production documentation, logistic activities, deviation management, shop floor optimization, and gap identification/resolution.
Requirements:
- At least 3 years of experience in pharmaceutical companies, with deep knowledge of aseptic production processes and GMP regulations.
- Strong organizational, personnel management, and communication skills, with ability to influence others.
- Deep understanding of digitalization and innovation-oriented mindset.
What We Offer:
- A competitive salary of €60,000 - €80,000 per annum, depending on experience.
- A dynamic and collaborative work environment with opportunities for growth and development.
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
Join Our Team:
Takeda is an equal opportunity employer committed to creating a diverse and inclusive workplace. We foster a culture of respect, empathy, and open communication, where every employee can thrive and contribute their best work.
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