Manufacturing Deviation and GMP Documentation Lead
3 settimane fa
Job Title: Manufacturing Deviation and GMP Documentation Lead
Location: Pisa
As a key member of our team, you will be responsible for ensuring the management of all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.
Key Responsibilities:
- Manage the execution of training on production documentation, ensuring strong training efficacy.
- Coordinate logistic activities for manufacturing and visual inspection.
- Investigate and resolve production deviations, including CAPA implementation.
- Identify and execute optimization on the shop floor to improve manufacturing efficiency.
- Collaborate with regulatory authorities during audits.
- Manage direct reports involved in production documentation, logistics, deviation management, and shop floor optimization.
- Establish goals and provide guidance to subordinates to achieve objectives in accordance with established policies.
Requirements:
- Degree in scientific disciplines (Chemistry & Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
- At least 5 years of experience in pharmaceutical companies and deep knowledge of aseptic production processes.
- Deep knowledge of GMP regulations and manufacturing of sterile products with RABS and Isolators.
- Good knowledge of English and main IT applications (Word, Excel, Power Point).
- Familiarity with digitalization of systems and processes.
- Strong relationship and communication skills, ability to influence others.
- Ability to take independent decisions based on data evaluation and risk assessment.
About Us:
Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive for excellence in everything we do.
Work Environment:
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.
Equal Employment Opportunities:
Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
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Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaAbout the Role:We are seeking a highly skilled and experienced Manufacturing Deviation and GMP Documentation Lead to join our team at Takeda. As a key member of our production team, you will be responsible for ensuring the management of all activities related to GMP production...
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Pisa, Toscana, Italia Takeda A tempo pienoJob Title: Manufacturing Deviation and GMP Documentation LeadLocation: PisaAs a key member of our team, you will be responsible for managing all activities related to GMP production documentation, including critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance. You will also be responsible for executing training...
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