Production Documentation Specialist
4 settimane fa
About the Role:
In the realm of production, management of documentation is crucial. This encompasses the creation, revision, and issuance of electronic Manufacturing Batch Records and Equipment Specifications, all in strict adherence to GDDP and cGMP standards.
As a subject-matter expert, overseeing production changes and conducting related risk assessments is important. Moreover, leading projects that enhance production processes and continuous improvement initiatives are key responsibilities.
Key Responsibilities:
- Complete Electrical Manufacturing Batch Record (MES), Equipment Specification (ESP) and related procedures revision, approval, issuance and related SOPs, according to GDDP rules and cGMP compliance.
- Implement training of Production documentation of its ownership.
- Be part of the execution of the Change Control as SME for production and support those through risk assessment (quality risk management).
- Collaborate with regulatory authorities' audits.
Requirements:
- A degree in Chemistry, Pharmaceutical Technologies, Biology, Biotechnology, or related engineering fields.
- Experience in pharmaceutical industry, especially in aseptic production.
- Regulatory Knowledge: Proficiency in GMP regulations, sterile manufacturing, RABS, and Isolators.
- Analytical Skills: critical thinking, problem-solving, and application of scientific methods.
- A team player able to collaborate across dynamic departments.
- Technological Proficiency: Digital and innovation orientation, familiarity with IT applications like Word, Excel, PowerPoint, and Trackwise System.
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.
Our Commitment:
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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