Computerized Systems Owner
vor 1 Tag
About the Role:
We are seeking a highly skilled Computerized Systems Owner to join our team at Takeda. As a key member of our quality control team, you will be responsible for the coordination, maintenance, and development of computerized systems in the GxP environment.
Your Responsibilities:
- Implement and maintain computerized systems in accordance with 9CFR pt 11, EU GMP Annex 11, and OECD advisory document requirements.
- Ensure all systems meet current GLP/GMP standards and guidelines for electronic records/signatures and data integrity.
- Lead the validation of computerized systems in collaboration with cross-functional teams.
- Develop user requirement specifications and SOPs.
- Provide training and support to end-users on system functionality and compliance requirements.
- Present at audits, focusing on maintenance activities, data integrity, and data security of computerized systems.
- Effectively communicate with stakeholders to ensure timely coordination.
- Continuously monitor best practices and regulatory changes related to computerized systems.
- Proactively identify opportunities for improvement.
- Maintain a high standard of professionalism and integrity in all interactions.
What You'll Bring:
- A degree in a relevant field, such as natural sciences, or equivalent experience in the pharmaceutical industry.
- Knowledge of GxP requirements for computerized systems.
- High sense of responsibility, reliability, and accuracy.
- Strong analytical and problem-solving skills, with excellent communication and interpersonal skills.
- Excellent language skills in German and English.
- Proficiency in IT tools, such as Office, ERP, and EQM systems.
About Takeda:
Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or any other characteristic protected by law.
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