Manufacturing Change Control & Gmp Documentation Lazio

Manufacturing Change Control & Gmp Documentation
Roma
Lazio, Lazio

Job Title: Manufacturing Change Control & GMP Documentation

Location: Province of Rieti, Italy

Client: Takeda

Job Category: Manufacturing

EU work permit required: Yes

Job Reference: 0e8d1ac9141f

Job Views: 17

Posted: 06. 03. 2025

Expiry Date: 20. 04. 2025

Job Description:The role involves overseeing GMP documentation management and revision, ensuring thorough and accurate processing.

It includes executing training programs to maintain high levels of competency, managing change requests, and conducting risk assessments to mitigate potential issues.

Additionally, the position supports various projects and plays a key role in preparing for both internal and external audits.

Responsibilities:Issue and review of GMP DocumentationSupport the maintenance of the GMP documentation archive related to own department, including the responsibility to collect and destroy documentsProject management and change request opening and managementCarrying out activities relating to GMP compliance in the field and operational problem solvingIdentification of improvement opportunities to align GMP compliance in productionWriting/Executing/reviewing RAPerformance of staff training regarding specific operating procedures, in compliance with the principles of Lean ManufacturingSupport in preparing and carrying out internal and external auditsMinimum Requirements:BS in life sciences or related fieldManufacturing experience of at least 1 yearGood science knowledge and main principles of pharmaceutical manufacturing equipmentKnowledge of cGMP with respect to the production processQuality risk managementExperience supporting MES implementationOrganizational and personnel management skillsRelationship and communication skillsGood knowledge of the English languageAbout Takeda:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

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.

Empowering our people to shine: 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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