GMP Compliance Documentation Specialist
3 settimane fa
About the Role:
As the Manufacturing Deviation and GMP Documentation Lead, you will oversee the management of all activities related to GMP production documentation. This includes the critical review, approval, issuance, and maintenance of documentation in accordance with GDDP rules and cGMP compliance standards.
Key Responsibilities:
- Guarantee production documentation critical revision, approval, issuance, and maintenance according to GDDP rules and cGMP compliance.
- Guarantee execution of training on production documentation, ensuring strong training efficacy.
- Guarantee logistic activities for manufacturing and visual inspection, including preparation and distribution of MBRs and VRs, creation of sampling labels, and revision of production documentation per GDP compliance.
- Guarantee execution/leading of investigations related to manufacturing/visual inspection department, applying appropriate tools and identifying/ executing related CAPAs when applicable.
- Collaborate with regulatory authorities' audits.
- Guarantee identification of gaps in manufacturing/visual inspection to fix those and identify/execute optimization on the shop floor.
Requirements:
- Degree in scientific disciplines (Chemistry Pharmaceutical Technologies, Biology, Biotechnology, Chemistry).
- Relevant years of experience in pharmaceutical companies and deep knowledge of aseptic production process.
- Deep knowledge of GMP regulations and manufacturing of sterile products with RABS and Isolators.
- Good knowledge of English and of the main IT applications (Word, Excel, Power Point).
- Previous use of Trackwise System.
- Familiarity and appetite for digitalization of systems/process.
- Strong relationship and communication skills, ability to influence other.
- Ability to take independent decisions based on data evaluation and risk evaluation.
- Strong team-working ability and results orientation as well as strong problem-solving skills.
About Takeda:
Takeda is a patient-focused company that will inspire and empower you 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.
Takeda is proud in 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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