Manufacturing Deviation and GMP Documentation Specialist
3 settimane fa
Job Description:
Purpose: We are seeking a highly skilled Manufacturing Deviation and GMP Documentation Specialist to join our team at Takeda. The successful candidate 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:
•Documentation Management: Guarantee the critical revision, approval, issuance, and maintenance of production documentation, including Master Batch Records, SOPs, forms, logbooks, and visual aids, according to GDDP rules and cGMP compliance.
•Training and Development: Ensure the execution of training on production documentation, guaranteeing strong training efficacy, and providing guidance to subordinates to achieve goals in accordance with established policies.
•Logistics and Data Management: Guarantee logistic activities for manufacturing and visual inspection, including the preparation and distribution of MBRs and VRs, creation of sampling labels, revision of production documentation per GDP compliance, and data management for trending purposes.
•Investigations and CAPA: Execute and lead investigations related to manufacturing and visual inspection departments, applying appropriate tools, and guarantee the identification and execution of related CAPAs when applicable.
•Audit Collaboration: Collaborate with regulatory authorities' audits and guarantee the identification of gaps in manufacturing and visual inspection to fix those, as well as the identification and execution of optimization on the shop floor.
Requirements:
•Education: Degree in scientific disciplines, such as Chemistry, Pharmaceutical Technologies, Biology, Biotechnology, or Chemistry.
•Experience: At least 5 years of experience in pharmaceutical companies and deep knowledge of aseptic production processes.
•Skills: Deep knowledge of GMP regulations, manufacturing of sterile products with RABS and Isolators, good knowledge of English, and main IT applications, previous use of Trackwise System, familiarity with digitalization of systems and processes.
Takeda Values:
We are a patient-focused company that inspires and empowers our people to grow through life-changing work. We foster an inclusive, collaborative workplace, 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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